Treating thermally injured children suffering symptoms of acute stress with imipramine and fluoxetine: a randomized, double-blind study.

Introduction: 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.

Method: 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.

Conclusion: Within the parameters of this study design and sample, placebo was statistically as effective as either drug in treating symptoms of ASD.