A Comparison of the Effect of Two Doses of Oral Melatonin as Premedication on Orientation Score, Induction Compliance, and Emergency Agitation of Children Undergoing Elective Surgeries: A Double-Blinded Randomized Trial

Background: Following sedation or general anesthesia, emergent agitation (EA) presents as a sequence of abrupt, complicated psychomotor problems marked by perceptual abnormalities, delusions, and disorientation. Studies have proved that melatonin significantly decreases the incidence of postoperative agitation in children after anesthesia. The primary objective of this study was to compare the effectiveness of two doses of oral melatonin as a premedication for orientation score, induction compliance, and emergency agitation of children undergoing surgeries. Methods: In this double-blinded randomized controlled trial, 126 children, aged 4-14, of either sex, with an ASA I or II, scheduled for elective surgery were randomly assigned to get either melatonin 0.4 mg/kg (Group M4) or melatonin 0.2 mg/kg (Group M2), with 63 kids in each group. All children have had the same anesthetic strategy. As a primary outcome, orientation score, induction compliance to intravenous induction anesthesia, and decreased emergency agitation were assessed. Results: Both groups were comparable in terms of demographic characteristics and baseline data. Orientation scores were similar between the groups. Preoperatively, all patients were oriented in both time and place. The two groups had no statistically significant difference according to induction compliance distribution (p = 0.065). There was a statistically significant difference in agitation behavior after 5, 10, and 15 min postoperatively in M 4, 2, and total participants (p < 0.001). Conclusion: In pediatric surgical patients, the melatonin dosage does not affect children's compliance with induction but impacts their postoperative behavior by reducing the likelihood of agitation. Administering oral melatonin before surgery could potentially aid in managing postoperative delirium in children.