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 1 mg/kg, with the maximum dose being 100 mg. Daily fluoxetine dose was 5 mg for children weighing ≥40 kg; 10 mg for those weighing between 40 and 60 kg; 20 mg 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.