Trial Outcomes & Findings for Dexmedetomidine vs Fentanyl for BMT (NCT NCT00654329)

Results Overview

Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2011-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine 1microgram/Kilogram Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal	Dexmedetomidine 2 Micrograms/Kilogram Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal	Fentanyl 2 Micrograms/Kilogram Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal	Normal Saline Placebo Normal saline placebo intranasal
Overall Study STARTED	23	28	23	27
Overall Study COMPLETED	23	28	23	27
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine vs Fentanyl for BMT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine 1microgram/Kilogram n=23 Participants Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal	Dexmedetomidine 2 Micrograms/Kilogram n=28 Participants Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal	Fentanyl 2 Micrograms/Kilogram n=23 Participants Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal	Normal Saline Placebo n=27 Participants Normal saline placebo intranasal	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	27 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	1.92 years STANDARD_DEVIATION .94 • n=5 Participants	2.17 years STANDARD_DEVIATION 1.51 • n=7 Participants	2.25 years STANDARD_DEVIATION 1.47 • n=5 Participants	2.17 years STANDARD_DEVIATION 1.66 • n=4 Participants	2.14 years STANDARD_DEVIATION 1.42 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants	66 Participants n=21 Participants
Region of Enrollment United States	23 participants n=5 Participants	28 participants n=7 Participants	23 participants n=5 Participants	27 participants n=4 Participants	101 participants n=21 Participants

PRIMARY outcome

Timeframe: up to 24 hours

Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1microgram/Kilogram n=23 Participants Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal	Dexmedetomidine 2 Micrograms/Kilogram n=28 Participants Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal	Fentanyl 2 Micrograms/Kilogram n=23 Participants Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal	Normal Saline Placebo n=27 Participants Normal saline placebo intranasal
Incidence of Pain	6 participants	11 participants	7 participants	18 participants

SECONDARY outcome

Timeframe: up to 24 hours

Total time from PACU entry until discharge

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1microgram/Kilogram n=23 Participants Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal	Dexmedetomidine 2 Micrograms/Kilogram n=28 Participants Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal	Fentanyl 2 Micrograms/Kilogram n=23 Participants Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal	Normal Saline Placebo n=27 Participants Normal saline placebo intranasal
Length of Stay in PACU	48 minutes Standard Deviation 26	88 minutes Standard Deviation 69	46 minutes Standard Deviation 25	48 minutes Standard Deviation 27

Adverse Events

Dexmedetomidine 1microgram/Kilogram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine 2 Micrograms/Kilogram

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fentanyl 2 Micrograms/Kilogram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexmedetomidine 1microgram/Kilogram n=23 participants at risk Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal	Dexmedetomidine 2 Micrograms/Kilogram n=28 participants at risk Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal	Fentanyl 2 Micrograms/Kilogram n=23 participants at risk Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal	Normal Saline Placebo n=27 participants at risk Normal saline placebo intranasal
Cardiac disorders Bradycardia	— 0/0	100.0% 1/1 • Number of events 1	— 0/0	— 0/0

Additional Information

Julia C. Finkel, MD

Children's National Medical Center

Phone: 202-476-4867

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place