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The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.
As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Active Comparator | Intraoperative administration for analgesia. |
|
| Dexmedetomidine 1mcg/kg | Active Comparator | Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia |
|
| Morphine 50 mcg/kg | Active Comparator | Intra-operative administration of morphine 50 mcg/kg for analgesia |
|
| Morphine 100mcg/kg | Active Comparator | Intra-operative administration of morphine 100mcg/kg for analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Drug | Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Post-Operative Rescue Morphine Required for Analgesia | From admission to discharge from PACU, up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Rescue Doses Needed by Participants | Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8. Minimum and Maximum values: minimum score: 4 & maximum score: 13. The higher the score ( > 8), the greater the pain appreciated by the patient. | From admission to discharge from PACU, up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olutoyin A Olutoye, M.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital, Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine 0.75 mcg/kg | Intraoperative administration for analgesia. Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. |
| FG001 | Dexmedetomidine 1mcg/kg | Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia |
| FG002 | Morphine 50 mcg/kg | Intra-operative administration of morphine 50 mcg/kg for analgesia Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia |
| FG003 | Morphine 100mcg/kg | Intra-operative administration of morphine 100mcg/kg for analgesia Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine 0.75 mcg/kg | Intraoperative administration for analgesia. Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. |
| BG001 | Dexmedetomidine 1mcg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Amount of Post-Operative Rescue Morphine Required for Analgesia | Posted | Mean | Standard Deviation | ug/kg | From admission to discharge from PACU, up to 1 hour |
|
Subjects were monitored from beginning of surgery until discharge from Post-Anesthetic Care Unit (PACU). There was no time limit on time monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine 0.75 mcg/kg | Intraoperative administration for analgesia. Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. |
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We studied a relatively healthy patient population and excluded children with documented sleep apnea by polysomnography.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olutoyin A. Olutoye, M.D., M.Sc. | Baylor College of Medicine | (832) 824-5800 | oao@bcm.edu |
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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 3, 2005 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Morphine 50 mcg/kg | Drug | Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia |
|
|
| Morphine 100 mcg/kg | Drug | Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia |
|
|
| Dexmedetomidine 1 mcg/kg | Drug | Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia |
|
|
| Duration of Oxygen Supplementation | The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU. | From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes |
| Time to PACU Discharge Readiness | Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU | From admission to discharge from PACU, no time limit |
| Number of Participants With Emergence Agitation | Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation. | From admission to discharge from PACU, no time limit |
| Number of Participants With Postoperative Complications | Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU | From admission to discharge from PACU, up to 1 hour |
Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia |
| BG002 | Morphine 50 mcg/kg | Intra-operative administration of morphine 50 mcg/kg for analgesia Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia |
| BG003 | Morphine 100mcg/kg | Intra-operative administration of morphine 100mcg/kg for analgesia Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Surgery | Mean | Standard Deviation | minutes |
|
| Duration of Anesthesia | Mean | Standard Deviation | minutes |
|
| Morphine 50 mcg/kg |
Intra-operative administration of morphine 50 mcg/kg for analgesia Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia |
| OG003 | Morphine 100mcg/kg | Intra-operative administration of morphine 100mcg/kg for analgesia Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia |
|
|
| Secondary | Morphine Rescue Doses Needed by Participants | Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8. Minimum and Maximum values: minimum score: 4 & maximum score: 13. The higher the score ( > 8), the greater the pain appreciated by the patient. | Posted | Count of Participants | Participants | From admission to discharge from PACU, up to 1 hour |
|
|
|
| Secondary | Duration of Oxygen Supplementation | The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU. | Posted | Mean | Standard Deviation | minutes | From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes |
|
|
|
| Secondary | Time to PACU Discharge Readiness | Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU | Posted | Mean | Standard Deviation | minutes | From admission to discharge from PACU, no time limit |
|
|
|
| Secondary | Number of Participants With Emergence Agitation | Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation. | Posted | Count of Participants | Participants | From admission to discharge from PACU, no time limit |
|
|
|
| Secondary | Number of Participants With Postoperative Complications | Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU | Posted | Count of Participants | Participants | From admission to discharge from PACU, up to 1 hour |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Dexmedetomidine 1mcg/kg | Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Morphine 50 mcg/kg | Intra-operative administration of morphine 50 mcg/kg for analgesia Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia | 0 | 30 | 0 | 30 | 0 | 30 |
| EG003 | Morphine 100mcg/kg | Intra-operative administration of morphine 100mcg/kg for analgesia Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia | 0 | 26 | 0 | 26 | 0 | 26 |
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| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 1 dose |
|
| >1 dose |
|
| Vomiting |
|