Overview

This trial is active, not recruiting.

Conditions pain, anxiety
Treatments clonidine, placebo
Sponsor The University of Texas, Galveston
Start date June 2004
End date June 2013
Trial size 60 participants
Trial identifier NCT00580151, 04-101, IFF 489030

Summary

Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
clonidine
3-5 microgram per kilogram every 6 hours for 10 days
(Placebo Comparator)
placebo
1 dose every 6 hours

Primary Outcomes

Measure
pain reduction
time frame: 10 days

Secondary Outcomes

Measure
anxiety reduction
time frame: 10 days

Eligibility Criteria

Male or female participants from 4 years up to 20 years old.

Inclusion Criteria: - Pain not controled by morphine - Anxiety not controled by lorazepam - Burn injuries of 20% or greater - Burn type: scald or flame Exclusion Criteria: - Small burn injury - Electrical burns

Additional Information

Official title The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Principal investigator Walter J. Meyer III, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by The University of Texas, Galveston.