the Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Information source: The University of Texas, Galveston
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Anxiety
Intervention: clonidine (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The University of Texas, Galveston Official(s) and/or principal investigator(s):
Walter J. Meyer III, MD, Principal Investigator, Affiliation: The University of Texas Medical Branch at Galveston
Overall contact:
Walter J. Meyer III, MD, Phone: (409) 747-8355, Email: wmeyer@utmb.edu
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.
Clinical Details
Official title: The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment
Primary outcome: pain reduction
Secondary outcome: anxiety reduction
Eligibility
Minimum age: 4 Years.
Maximum age: 20 Years.
Gender(s): Both.
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
Locations and Contacts
Walter J. Meyer III, MD, Phone: (409) 747-8355, Email: wmeyer@utmb.edu
Shriners hospital for Children; Shriners Burns Hospital, Galveston, Texas 77550, United States; Recruiting
Walter J. Meyer, M.D., Phone: 409-747-8355, Email: wmeyer@utmb.edu
Walter J. Meyer, M.D., Principal Investigator
Additional Information
Starting date: June 2004
Ending date: June 2009
Last updated: June 6, 2008
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