Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Interventions
- DRUG placebo
- DRUG clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-06 |
| Est. Completion | 2014-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00580151
The ClinicalTrials.gov registry entry for NCT00580151 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00580151 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.