Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-13 @ 5:21 AM
Study NCT ID:
NCT00580151
Status:
TERMINATED
Last Update Posted:
2015-02-23
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to no response from PI to IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
clonidine
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IFFA | OTHER | International Firefighters Association | View |