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NCT00580151 · ClinicalTrials.gov registry record · NA
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT00580151: Clinical Trial NA study, sponsored by The University of Texas Medical Branch, Galveston.
NCT00580151 is a NA study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00580151, a NA study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG placebo
- DRUG clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-06 |
| Est. Completion | 2014-06 |
| Phase | NA |
Why NCT00580151 stopped before completion
NCT00580151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00580151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00580151 about?
NCT00580151 is a clinical study titled "The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children". 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 ...
What is the current status of trial NCT00580151?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2004-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00580151?
The interventions under investigation include: placebo (DRUG), clonidine (DRUG).
Who is sponsoring clinical trial NCT00580151?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00580151's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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