Treating thermally injured children suffering symptoms of acute stress with imipramine and fluoxetine: a randomized, double-blind study.
BACKGROUND
For pediatric burn patients with the symptoms of acute stress disorder (ASD) a first line medication is not widely agreed upon. A prospective, randomized, placebo controlled, double-blind design was used to test the efficacy of imipramine and fluoxetine.


METHODS
Patients 4-18 years of age with symptoms of ASD were randomized to 1 of 3 groups: imipramine, fluoxetine, or placebo for 1 week. Daily imipramine dose was 1mg/kg, with the maximum dose being 100mg. Daily fluoxetine dose was 5mg for children weighing >or=40 kg; 10mg for those weighing between 40 and 60 kg; 20mg for those weighing >60 kg.


RESULTS
Sixty participants, 16 females and 44 males, had an average body surface area burn of 53% (S.D.=18) and average age of 11 years (S.D.=4). Imipramine subjects received an average daily dose of 1.00+/-0.29 mg/kg. Fluoxetine subjects received an average daily dose of 0.29+/-0.16 mg/kg. Between group differences were not detected. Fifty-five percent responded positively to placebo; 60% responded positively to imipramine; and 72% responded positively to fluoxetine.


CONCLUSIONS
Within the parameters of this study design and sample, placebo was statistically as effective as either drug in treating symptoms of ASD.
Robert
Rhonda
R
Shriners Hospitals for Children, Galveston, TX 77550, USA.
Tcheung
Win J
WJ
Rosenberg
Laura
L
Rosenberg
Marta
M
Mitchell
Charles
C
Villarreal
Cynthia
C
Thomas
Christopher
C
Holzer
Charles
C
Meyer
Walter J
WJ
D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D002056:Burns / Q000523:psychology*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D007099:Imipramine / Q000627:therapeutic use*; D008297:Male; D010919:Placebos; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D040701:Stress Disorders, Traumatic, Acute / Q000188:drug therapy*; D013315:Stress, Psychological; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D005473:Fluoxetine; D007099:Imipramine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors