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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24TR001608 | U.S. NIH Grant/Contract | View source |
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Enrollment challenging during the pandemic COVID 19
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Johns Hopkins University | OTHER |
| Intermountain Health Care, Inc. | OTHER |
| Vanderbilt University Medical Center |
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Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children.
This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.
Phase 1b randomized, double-blind, placebo-controlled dose escalation trial of sedation regimens in critically ill children. Testing the hypothesis of mean daily fentanyl dose through day 7 of mechanical ventilation will be reduced by ≥25% by the addition of dexmedetomidine to fentanyl therapy. This trial will involve multiple clinical sites. Randomization will occur by individual and investigators will be blinded to study/treatment arm. The statistical analysis will account for center effects, participant characteristics (including post-surgical state), and changes over time to minimize bias. In addition, PIs and study coordinators will undergo training to standardize assessment procedures. The study will randomize participants to receive placebo (fentanyl standard of care) titrated to sedation+saline placebo (bolus+infusion) or one of the following 3 Dexmedetomidine treatment arms in a sequential cohort fashion: Cohort 1: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2 mcg/kg/hr infusion); Cohort 2: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion); and, Cohort 3: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion).
An interim analysis is planned for this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fen. SOC+saline placebo (bolus+infusion) | Placebo Comparator | Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion) |
|
| Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Active Comparator | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Active Comparator | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) |
|
| Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Active Comparator | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour) | Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Based on the State Behavior Scale (SBS) Relative to Fentanyl Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Cornell Assessment of Pediatrics in Delirium (CAPD) Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. |
Inclusion Criteria:
Exclusion Criteria:
Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Benjamin, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| University of Florida, Shands Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36577492 | Derived | Boutzoukas AE, Olson R, Sellers MA, Fischer G, Hornik CD, Alibrahim O, Iheagwara K, Abulebda K, Bass AL, Irby K, Subbaswamy A, Zivick EE, Sweney J, Stormorken AG, Barker EE, Lutfi R, McCrory MC, Costello JM, Ackerman KG, Munoz Pareja JC, Dean JM, Abdelsamad N, Hanley DF Jr, Mould WA, Lane K, Stroud M, Feger BJ, Greenberg RG, Smith PB, Benjamin DK Jr, Hornik CP, Zimmerman KO, Becker ML. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience. Contemp Clin Trials. 2023 Feb;125:107067. doi: 10.1016/j.cct.2022.107067. Epub 2022 Dec 25. |
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Subjects enrolled were in a pediatric intensive care setting, critically ill and requiring ventilatory support and pain management associated with such.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion) Fentanyl: Fentanyl standard of care |
| FG001 | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2020 |
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| OTHER |
Phase 1b randomized, double-blind, placebo-controlled dose escalation trial. The study will randomize participants to receive placebo (fentanyl standard of care) titrated to sedation+saline placebo (bolus+infusion) or one of the following 3 Dexmedetomidine treatment arms in a sequential cohort fashion: Cohort 1: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2 mcg/kg/hr infusion); Cohort 2: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion); Cohort 3: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion).
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| Dexmedetomidine | Drug | Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr) |
|
| Dexmedetomidine | Drug | Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
|
| Dexmedetomidine | Drug | Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on Richmond Agitation and Sedation Scale (RASS) Scale Relative to Fentanyl Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-pint scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Number of Participants Experiencing a Clinically Significant Episode of Hypotension | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | up to 28 days or until discharge from the ICU (whichever is first) |
| Number of Participants Experiencing SAEs (Serious Adverse Events) | up to 28 days or until discharge from the ICU (whichever is first) |
| Mean Number of SAEs (Serious Adverse Events) Experienced by Participants | up to 28 days or until discharge from the ICU (whichever is first) |
| Number of Participants Experiencing a Clinically Significant Episode of Bradycardia | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | up to 28 days or until discharge from the ICU (whichever is first) |
| Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | up to 28 days or until discharge from the ICU (whichever is first) |
| through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Maximum Daily CAPD Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Minimum Daily CAPD Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Average Daily Withdrawal Assessment Tool (WAT-1) Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Minimum Daily WAT-1 Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Maximum Daily WAT-1 Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Indiana University Health, Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Our Lady of the Lake Children's Hospital | Baton Rouge | Louisiana | 70808 | United States |
| UMass Memorial Medical Center, Children's Center | Worcester | Massachusetts | 01655 | United States |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | United States |
| Saint Louis University, Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| University of New Mexico Children's Hospital | Albuquerque | New Mexico | 87131 | United States |
| University of Buffalo, Oishei Children's Hospital | Buffalo | New York | 14203 | United States |
| University of Rochester Medical Center, Golisano Children's Hospital | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Rainbow Babies and Children's Hospital, University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| MetroHealth System, Case CTSA | Cleveland | Ohio | 44109 | United States |
| Oregon Health and Science University, Doernbecher Children's Hospital | Portland | Oregon | 97239 | United States |
| Drexel University, St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Medical University of South Carolina Children's Hospital | Charleston | South Carolina | 29425 | United States |
| University of Texas - Health Science Center San Antonio | San Antonio | Texas | 78229 | United States |
| Primary Children's Medical Center- University of Utah | Salt Lake City | Utah | 84113 | United States |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)
Fentanyl: Fentanyl standard of care
Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)
| FG002 | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| FG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Study was prematurely terminated and no participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion) Fentanyl: Fentanyl standard of care |
| BG001 | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr) |
| BG002 | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| BG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour) | Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine. | Patients who did not have fentanyl reported were excluded. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Mean | Standard Deviation | mcg/kg/hr | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
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| Secondary | Sedation Based on the State Behavior Scale (SBS) Relative to Fentanyl Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
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| Secondary | Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on Richmond Agitation and Sedation Scale (RASS) Scale Relative to Fentanyl Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-pint scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Css) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC) | Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. | Data not collected. The study was terminated early due to enrollment challenges. | Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing a Clinically Significant Episode of Hypotension | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Count of Participants | Participants | up to 28 days or until discharge from the ICU (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing SAEs (Serious Adverse Events) | No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Count of Participants | Participants | up to 28 days or until discharge from the ICU (whichever is first) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of SAEs (Serious Adverse Events) Experienced by Participants | Participants who experienced at least one SAE. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Mean | Standard Deviation | serious adverse events | up to 28 days or until discharge from the ICU (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing a Clinically Significant Episode of Bradycardia | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Count of Participants | Participants | up to 28 days or until discharge from the ICU (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention | Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation. | Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group. | Posted | Count of Participants | Participants | up to 28 days or until discharge from the ICU (whichever is first) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Average Daily Cornell Assessment of Pediatrics in Delirium (CAPD) Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Daily CAPD Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minimum Daily CAPD Scores | Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Average Daily Withdrawal Assessment Tool (WAT-1) Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minimum Daily WAT-1 Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Daily WAT-1 Score | Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better. | Not Posted | through day 7 of mechanical ventilation or initial extubation (whichever is first) | Participants |
Up to 28 days or until discharge from the ICU (whichever is first)
No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion) Fentanyl: Fentanyl standard of care | 0 | 6 | 0 | 6 | 4 | 6 |
| EG001 | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr) | 0 | 12 | 2 | 12 | 9 | 12 |
| EG002 | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) | 0 | 12 | 1 | 12 | 8 | 12 |
| EG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General signs and symptoms NEC | General disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Colitis (excl infective) | Gastrointestinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Seizures and seizure disorder NEC | Nervous system disorders | MedDRA High Level | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaesthetic and allied procedural complications | Injury, poisoning and procedural complications | MedDRA High Level | Non-systematic Assessment |
| |
| Anxiety symptoms | Psychiatric disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Bladder and urethral symptoms | Renal and urinary disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Colitis (excl infective) | Gastrointestinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Conditions associated with abnormal gas exchange | Respiratory, thoracic and mediastinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Encephalopathies NEC | Nervous system disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Febrile disorders | General disorders | MedDRA High Level | Non-systematic Assessment |
| |
| General signs and symptoms NEC | General disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Heart rate and pulse investigations | Investigations | MedDRA High Level | Non-systematic Assessment |
| |
| Hepatic failure and associated disorders | Hepatobiliary disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Laryngeal spasm, oedema and obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Magnesium metabolism disorders | Metabolism and nutrition disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Nausea and vomiting symptoms | Gastrointestinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Parainfluenzae viral infections | Infections and infestations | MedDRA High Level | Non-systematic Assessment |
| |
| Pneumothorax and pleural effusions NEC | Respiratory, thoracic and mediastinal disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Protein metabolism disorders NEC | Metabolism and nutrition disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Rate and rhythm disorders NEC | Cardiac disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Renal failure and impairment | Renal and urinary disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Respiratory tract and thoracic cavity procedural complications | Injury, poisoning and procedural complications | MedDRA High Level | Non-systematic Assessment |
| |
| Seizures and seizure disorders NEC | Nervous system disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Stereotypies and automatisms | Psychiatric disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Tremor (excl congenital) | Nervous system disorders | MedDRA High Level | Non-systematic Assessment |
| |
| Vascular hypotensive disorders | Vascular disorders | MedDRA High Level | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara L. Becker, MD, MSCE | Duke University | 919-613-1942 | mara.becker@duke.edu |
| Aug 30, 2021 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2020 | Feb 4, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
|
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) |
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) |
| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)
Fentanyl: Fentanyl standard of care
Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
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Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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| OG003 | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) |
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