Trial Outcomes & Findings for Dexmedetomidine in Pediatric Tonsillectomy (NCT NCT01057381)
NCT ID: NCT01057381
Last Updated: 2021-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
From admission to discharge from PACU, up to 1 hour
Results posted on
2021-07-27
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
30
|
26
|
|
Overall Study
COMPLETED
|
26
|
27
|
30
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
30 Participants
n=30 Participants
|
26 Participants
n=26 Participants
|
109 Participants
n=109 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=109 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=109 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=26 Participants
|
16 Participants
n=27 Participants
|
15 Participants
n=30 Participants
|
16 Participants
n=26 Participants
|
65 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=26 Participants
|
11 Participants
n=27 Participants
|
15 Participants
n=30 Participants
|
10 Participants
n=26 Participants
|
44 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
27 participants
n=27 Participants
|
30 participants
n=30 Participants
|
26 participants
n=26 Participants
|
109 participants
n=109 Participants
|
|
Duration of Surgery
|
22.0 minutes
STANDARD_DEVIATION 8.4 • n=26 Participants
|
21.3 minutes
STANDARD_DEVIATION 9.7 • n=27 Participants
|
22.8 minutes
STANDARD_DEVIATION 7.6 • n=30 Participants
|
26.0 minutes
STANDARD_DEVIATION 9.5 • n=26 Participants
|
23.0 minutes
STANDARD_DEVIATION 8.9 • n=109 Participants
|
|
Duration of Anesthesia
|
48.2 minutes
STANDARD_DEVIATION 19.3 • n=26 Participants
|
44.7 minutes
STANDARD_DEVIATION 10.8 • n=27 Participants
|
43.3 minutes
STANDARD_DEVIATION 9.7 • n=30 Participants
|
49.6 minutes
STANDARD_DEVIATION 13.3 • n=26 Participants
|
46.3 minutes
STANDARD_DEVIATION 13.7 • n=109 Participants
|
PRIMARY outcome
Timeframe: From admission to discharge from PACU, up to 1 hourOutcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Amount of Post-Operative Rescue Morphine Required for Analgesia
|
45.2 ug/kg
Standard Deviation 30.8
|
37.0 ug/kg
Standard Deviation 25.4
|
43.3 ug/kg
Standard Deviation 23.6
|
36.5 ug/kg
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: From admission to discharge from PACU, up to 1 hourSubjects 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.
Outcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Morphine Rescue Doses Needed by Participants
0 dose
|
6 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Morphine Rescue Doses Needed by Participants
1 dose
|
2 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
|
Morphine Rescue Doses Needed by Participants
>1 dose
|
18 Participants
|
10 Participants
|
16 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutesThe 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.
Outcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Duration of Oxygen Supplementation
|
17 minutes
Standard Deviation 11
|
19 minutes
Standard Deviation 12
|
20 minutes
Standard Deviation 19
|
18 minutes
Standard Deviation 14
|
SECONDARY outcome
Timeframe: From admission to discharge from PACU, no time limitPatients 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
Outcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Time to PACU Discharge Readiness
|
115 minutes
Standard Deviation 0.04
|
116 minutes
Standard Deviation 0.03
|
117 minutes
Standard Deviation 0.03
|
122 minutes
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: From admission to discharge from PACU, no time limitPatients 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.
Outcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Emergence Agitation
|
5 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From admission to discharge from PACU, up to 1 hourPost-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU
Outcome measures
| Measure |
Dexmedetomidine 0.75 mcg/kg
n=26 Participants
Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
|
Dexmedetomidine 1mcg/kg
n=27 Participants
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
|
Morphine 50 mcg/kg
n=30 Participants
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
|
Morphine 100mcg/kg
n=26 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Postoperative Complications
Nausea
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Postoperative Complications
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Dexmedetomidine 0.75 mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine 1mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Morphine 50 mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Morphine 100mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Olutoyin A. Olutoye, M.D., M.Sc.
Baylor College of Medicine
Phone: (832) 824-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place