Trial Outcomes & Findings for Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (NCT NCT00654511)
NCT ID: NCT00654511
Last Updated: 2021-03-23
Results Overview
Total minutes from study medication administration to time of first morphine dose.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
up to 24 hours
Results posted on
2021-03-23
Participant Flow
Participant milestones
| Measure |
Fentanyl 1 Microgram/Kilogram Intravenous (IV)
Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
|
Fentanyl 2 Micrograms/Kilogram Intravenous (IV)
Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
|
Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)
Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
|
Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
26
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Baseline characteristics by cohort
| Measure |
Fentanyl 1 Microgram/Kilogram Intravenous (IV)
n=26 Participants
Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
|
Fentanyl 2 Micrograms/Kilogram Intravenous (IV)
n=25 Participants
Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
|
Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)
n=25 Participants
Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
|
Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
n=25 Participants
Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
4.17 years
STANDARD_DEVIATION 2.33 • n=5 Participants
|
4.83 years
STANDARD_DEVIATION 2.45 • n=7 Participants
|
5.17 years
STANDARD_DEVIATION 2.33 • n=5 Participants
|
4.92 years
STANDARD_DEVIATION 2.27 • n=4 Participants
|
4.77 years
STANDARD_DEVIATION 2.34 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
101 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 24 hoursTotal minutes from study medication administration to time of first morphine dose.
Outcome measures
| Measure |
Fentanyl 1 Microgram/Kilogram IV
n=26 Participants
|
Fentanyl 2 Micrograms/Kilogram IV
n=25 Participants
|
Dexmedetomidine 2 Microgram/Kilogram IV
n=25 Participants
|
Dexmedetomidine 4 Micrograms/Kilogram IV
n=25 Participants
|
|---|---|---|---|---|
|
Time to First Morphine Dose
|
19 minutes
Standard Deviation 24.8
|
43.7 minutes
Standard Deviation 61.4
|
61.1 minutes
Standard Deviation 89.5
|
137.6 minutes
Standard Deviation 123.2
|
PRIMARY outcome
Timeframe: up to 24 hoursTotal morphine administered in the Post Anesthesia Care Unit (PACU)
Outcome measures
| Measure |
Fentanyl 1 Microgram/Kilogram IV
n=26 Participants
|
Fentanyl 2 Micrograms/Kilogram IV
n=25 Participants
|
Dexmedetomidine 2 Microgram/Kilogram IV
n=25 Participants
|
Dexmedetomidine 4 Micrograms/Kilogram IV
n=25 Participants
|
|---|---|---|---|---|
|
Morphine Rescue
|
84 micrograms/kilogram
Standard Deviation 37
|
95 micrograms/kilogram
Standard Deviation 44
|
85 micrograms/kilogram
Standard Deviation 37
|
59 micrograms/kilogram
Standard Deviation 44
|
Adverse Events
Fentanyl 1 Microgram/Kilogram Intravenous (IV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl 2 Micrograms/Kilogram Intravenous (IV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place