BACKGROUND AND OBJECTIVE: 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. METHODS: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. RESULTS: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. DISCUSSION: 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.
RCT Entities:
BACKGROUND AND OBJECTIVE: 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. METHODS: 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. RESULTS: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. DISCUSSION: 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.