Clinical trial NCT00580151: The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Official title: The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Pain not controled by morphine
Anxiety not controled by lorazepam
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 9
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Reduction
timeFrame: Average of the 10 days
Secondary outcomes:
measure: Anxiety Reduction
timeFrame: Average of the 10 days
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Shriners Hospital for Children; Shriners Burns Hospital
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch at Galveston
name: Walter J. Meyer III, MD
role: PRINCIPAL_INVESTIGATOR
References: