Trial Outcomes & Findings for The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children (NCT NCT00580151)

Results Overview

The scale name is "FACES" (Faces Pain Rating Scale). Subjects were asked "rate your WORST PAIN today" (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Average of the 10 days

Results posted on

2015-02-23

Participant Flow

Patients recruited in the medical clinic. Recruitment occured between 11/10/04-7/16/05.

All participants were eligible to participate in the study.

Participant milestones

Participant milestones
Measure	Experimental Group clonidine : 3-5 microgram per kilogram every 6 hours for 10 days	Control Group placebo : 1 dose every 6 hours
Overall Study STARTED	9	0
Overall Study COMPLETED	9	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=9 Participants clonidine : 3-5 microgram per kilogram every 6 hours for 10 days	Control Group placebo : 1 dose every 6 hours	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	9 participants n=5 Participants	—	9 participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Continuous	7.8 years STANDARD_DEVIATION 3.2 • n=5 Participants	—	7.8 years STANDARD_DEVIATION 3.2 • n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	8 participants n=5 Participants	—	8 participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	—	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Average of the 10 days

Population: Determined by the number of patients recruited.

The scale name is "FACES" (Faces Pain Rating Scale). Subjects were asked "rate your WORST PAIN today" (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.

Outcome measures

Outcome measures
Measure	Experimental Group n=9 Participants clonidine : 3-5 microgram per kilogram every 6 hours for 10 days	Control Group placebo : 1 dose every 6 hours
Pain Reduction	.73 units on a scale Interval 0.0 to 4.0	—

SECONDARY outcome

Timeframe: Average of the 10 days

Population: Patients analyzed were all patients consented.

The "Fear Thermometer" measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days.

Outcome measures

Outcome measures
Measure	Experimental Group n=9 Participants clonidine : 3-5 microgram per kilogram every 6 hours for 10 days	Control Group placebo : 1 dose every 6 hours
Anxiety Reduction	.76 units on a scale Interval 0.0 to 4.0	—

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Walter Meyer, M.D.

University of Texas-Galveston

Phone: 409-770-6718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place