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| ID | Type | Description | Link |
|---|---|---|---|
| ZIN-DEX-1506 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Maruishi Pharmaceutical | INDUSTRY |
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To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care unit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-9501 | Experimental | A single vial contains an injection solution with 2 mL of dexmedetomidine hydrochloride solution (100 µg/mL as dexmedetomidine) dissolved in physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs. |
Inclusion Criteria:
Exclusion Criteria:
Subjects who are judged by investigator or sub-investigator to have a neurological disease that will make sedation assessment difficult, such as:
Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker).
Subjects with any of the following low blood pressure levels during the tests at the screening visit:
Subject of bradycardia (≤10th centile of heart rate for healthy children) during the physical examination at screening period.
Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit.
Subjects in whom dexmedetomidine or other alfa 2 receptor agonists, alfa 2 receptor antagonists and drug that may be used in this study are contraindicated.
Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product.
Subjects who have acute febrile illness [with a temperature (core or tympanic) ≥ 38.0°Centigrade] at the screening visit.
Subjects who received other investigational product within 30 days before baseline or subjects who will participate in other study that uses an investigational product during the study period.
Subjects who received dexmedetomidine within 48 hours before baseline.
Subjects who, in the opinion of the investigator or sub-investigator, may be at increased risk to the subject due to the conduct of the study or may have a disease or factor which will probably preclude the obtainment of sufficient study data.
Subjects for whom, in the opinion of the investigator or sub-investigator, risks involved with administration of dexmedetomidine outweigh its benefits (e.g., >2 doses of vasopressor due to cardiogenic shock).
Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Sponsor's employees directly involved in the conduct of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asahikawa Medical University Hospital | Asahikawa | Hokkaido | 078-8510 | Japan | ||
| Hyogo Prefectural Kobe Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33813550 | Derived | Takeuchi M, Nemoto S, Suzuki Y, Takahashi N, Takenaka N, Takata A, Kobayashi M. Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan. Pediatr Crit Care Med. 2021 Nov 1;22(11):e546-e557. doi: 10.1097/PCC.0000000000002730. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine: >=45 Weeks CGA to <12 Months | Participants with age between >=45 weeks corrected gestation age (CGA) to <12 months received 0.2 microgram per kilogram per hour (mcg/kg/h) of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| FG001 | Dexmedetomidine: >=12 Months to <24 Months | Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| FG002 | Dexmedetomidine: >=2 Years to <6 Years | Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| FG003 | Dexmedetomidine: >=6 Years to <17 Years | Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) included all participants who have received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine: >=45 Weeks CGA to <12 Months | Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. | FAS included all participants who received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
Baseline up to 28 days after end of study drug dosing (Day 56)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
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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: >=45 Weeks CGA to <12 Months | Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2016 | May 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2017 | May 16, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
| Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
| Duration of Maintenance of Target Sedation Level After Extubation | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Percentage of Maintenance Duration of Target Sedation Level After Extubation | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Total Amount of Rescue Sedative Taken After Extubation | Total amount of rescue sedative (Midazolam) administered by the participants after extubation. | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg). | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Total Amount of Rescue Analgesic Taken After Extubation | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg). | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
| Median Time to Conclusion of Mechanical Ventilation | Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation. | Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days) |
| Baseline up to 28 days after end of study drug dosing (up to 56 days) |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision. | Baseline up to 28 days after end of study drug dosing (Day 56) |
| Number of Participants With Laboratory Test Abnormalities | Criteria for abnormality: hemoglobin, hematocrit and red blood cell count <0.8*lower limit of normal(LLN); platelet <0.5*LLN; >1.75*upper limit of normal(ULN); white blood cell count <0.6*LLN; >1.5*ULN; lymphocytes, neutrophils and stab cells <0.8*LLN; >1.2*ULN; eosinophils, basophils and monocytes >1.2*ULN; total bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase >3*ULN; total protein and albumin <0.8*LLN; >1.2*ULN; glucose <0.6*LLN; >1.5*ULN; blood urea nitrogen and creatinine >1.3*ULN; uric acid >1.2*ULN; sodium <0.95*LLN; >1.05*ULN, potassium, calcium and magnesium <0.9*LLN; >1.1*ULN; phosphate <0.8*LLN; >1.2*ULN. | Baseline up to 28 days after end of study drug dosing (Day 56) |
| Total Input/Output Fluid Volume | Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period. | Baseline up to 28 days after end of study drug dosing (Day 56) |
| Incidence of Potential Withdrawal Symptoms | The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms. | Baseline up to 28 days after end of study drug dosing (Day 56) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision. | Baseline up to 28 days after end of study drug dosing (Day 56) |
| Kobe |
| Hyōgo |
| 650-0047 |
| Japan |
| Shikoku Medical Center for Children and Adults | Zentsujichó | Kagawa-ken | 765-8507 | Japan |
| Osaka Women's and Children's Hospital | Izumi | Osaka | 594-1101 | Japan |
| Osaka Medical College Hospital | Takatsuki | Osaka | 569-8686 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329-0498 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Metropolitan Children's Medical Center | Fuchū | Tokyo | 183-8561 | Japan |
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Shizuoka Children's Hospital | Shizuoka | 420-8660 | Japan |
| To obtain contact information for a study center near you, click here. | View source |
| Adverse Event |
|
| Dexmedetomidine: >=12 Months to <24 Months |
Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| BG002 | Dexmedetomidine: >=2 Years to <6 Years | Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| BG003 | Dexmedetomidine: >=6 Years to <17 Years | Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| BG004 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Dexmedetomidine: >=45 Weeks CGA to <12 Months | Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| OG001 | Dexmedetomidine: >=12 Months to <24 Months | Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| OG002 | Dexmedetomidine: >=2 Years to <6 Years | Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| OG003 | Dexmedetomidine: >=6 Years to <17 Years | Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
| OG004 | Dexmedetomidine: All Participants | Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. |
|
|
| Secondary | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported. | FAS included all participants who received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
|
|
|
| Secondary | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). | Posted | Mean | Standard Deviation | milligrams (mg) | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
|
|
|
| Secondary | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). | Posted | Mean | Standard Deviation | mg/kg | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
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| Secondary | Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | micrograms | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
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| Secondary | Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | mcg/kg | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
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| Secondary | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. | FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | hours | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
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| Secondary | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | percentage of time | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) |
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| Secondary | Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. | Participants from FAS population whose period of dosing of investigational product exceeded 24 hours. | Posted | Number | 95% Confidence Interval | percentage of participants | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported. | Participants from FAS population whose period of dosing of investigational product exceeded 24 hours. | Posted | Number | 95% Confidence Interval | percentage of participants | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). | Posted | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). | Posted | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). | Posted | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). | Posted | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability. | Participants from FAS population whose period of dosing of investigational product exceeded 24 hours. | Posted | Mean | Standard Deviation | hours | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | Participants from FAS population whose period of dosing of investigational product exceeded 24 hours. | Posted | Mean | Standard Deviation | percentage of time | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) |
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| Secondary | Duration of Maintenance of Target Sedation Level After Extubation | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. | FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | hours | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Percentage of Maintenance Duration of Target Sedation Level After Extubation | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. | FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | Percentage of time | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Total Amount of Rescue Sedative Taken After Extubation | Total amount of rescue sedative (Midazolam) administered by the participants after extubation. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | mg | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | mg/kg | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Total Amount of Rescue Analgesic Taken After Extubation | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | mcg | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg). | Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | mcg/kg | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) |
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| Secondary | Median Time to Conclusion of Mechanical Ventilation | Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation. | FAS: all participants who received at least one dose of the investigational product. | Posted | Median | Full Range | hours | Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days) |
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| Other Pre-specified | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs. | Safety analysis set included all participants who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline up to 28 days after end of study drug dosing (up to 56 days) |
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision. | Safety analysis set included all participants who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline up to 28 days after end of study drug dosing (Day 56) |
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| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities | Criteria for abnormality: hemoglobin, hematocrit and red blood cell count <0.8*lower limit of normal(LLN); platelet <0.5*LLN; >1.75*upper limit of normal(ULN); white blood cell count <0.6*LLN; >1.5*ULN; lymphocytes, neutrophils and stab cells <0.8*LLN; >1.2*ULN; eosinophils, basophils and monocytes >1.2*ULN; total bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase >3*ULN; total protein and albumin <0.8*LLN; >1.2*ULN; glucose <0.6*LLN; >1.5*ULN; blood urea nitrogen and creatinine >1.3*ULN; uric acid >1.2*ULN; sodium <0.95*LLN; >1.05*ULN, potassium, calcium and magnesium <0.9*LLN; >1.1*ULN; phosphate <0.8*LLN; >1.2*ULN. | Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Count of Participants | Participants | Baseline up to 28 days after end of study drug dosing (Day 56) |
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| Other Pre-specified | Total Input/Output Fluid Volume | Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period. | Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Mean | Standard Deviation | milliliters (mL) | Baseline up to 28 days after end of study drug dosing (Day 56) |
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| Other Pre-specified | Incidence of Potential Withdrawal Symptoms | The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms. | Safety analysis set included all participants who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline up to 28 days after end of study drug dosing (Day 56) |
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| Other Pre-specified | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision. | Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure. | Posted | Count of Participants | Participants | Baseline up to 28 days after end of study drug dosing (Day 56) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 11 |
| 14 |
| EG001 | Dexmedetomidine: >=12 Months to <24 Months | Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 0 | 18 | 0 | 18 | 16 | 18 |
| EG002 | Dexmedetomidine: >=2 Years to <6 Years | Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 0 | 19 | 1 | 19 | 16 | 19 |
| EG003 | Dexmedetomidine: >=6 Years to <17 Years | Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 0 | 12 | 0 | 12 | 12 | 12 |
| EG004 | Dexmedetomidine: All Participants | Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 0 | 63 | 1 | 63 | 55 | 63 |
| Bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| SAEs |
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| Output Volume |
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| Abdominal discomfort |
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| Abdominal pain |
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| Dry mouth |
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| Nausea |
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| Vomiting |
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| Injection site pain |
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| Pyrexia |
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| Body temperature increased |
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| Electrocardiogram QT prolonged |
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| Neuralgia |
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| Agitation |
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| Atelectasis |
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| Oropharyngeal pain |
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| Hypotension |
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