Melatonin vs. midazolam premedication in children: a double-blind, placebo-controlled study

Abstract

Unlike midazolam, melatonin premedication is not associated with cognitive impairment in adults despite its anxiolytic properties. The use of melatonin as a premedicant in children has not been reported. This randomized, double-blind, placebo-controlled study compared the perioperative effects of different doses of melatonin and midazolam in children. Seven groups of children (n = 15 in each) were randomly assigned to receive one of the following premedicants. Midazolam 0.1, 0.25 or 0.5 mg kg(-1) orally, melatonin 0.1, 0.25 or 0.5 mg kg(-1) orally each mixed in 15 mg kg(-1) acetaminophen, or placebo only (15 mg kg(-1) acetaminophen). Anxiety and temperament were evaluated before and after administration of the study drug, on separation from parents and on the introduction of the anaesthesia mask. At week 2 postoperatively, the behaviour of the children was measured by the Post Hospitalization Behaviour Questionnaire. Melatonin or midazolam each in doses of 0.25 or 0.5 mg kg(-1) were equally effective as premedicants in alleviating separation anxiety and anxiety associated with the introduction of the anaesthesia mask. A trend was noted for midazolam to prolong recovery times as the dosage increased. The use of melatonin was associated with a lower incidence (P = 0.049) of excitement at 10 min postoperatively, and a lower incidence (P = 0.046) of sleep disturbance at week 2 postoperatively than that observed with midazolam and control groups. No postoperative excitement was noted in the melatonin groups at 20, 30 and 45 min. Melatonin was not only as effective as midazolam in alleviating preoperative anxiety in children, but it was also associated with a tendency towards faster recovery, lower incidence of excitement postoperatively and a lower incidence of sleep disturbance at week 2 postoperatively.