A Blind Randomized Trial Comparing Different Doses of Oral Melatonin with Placebo as Premedication in Pediatrics to Alleviate Preoperative Anxiety

Background and objectives: In children, preoperative anxiety in is known to be associated with different postoperative issues, such as regressive behavioral changes, prolonged recovery distress, eating disorders, and bedwetting. Administering pre-anesthetics and sedatives orally is a reliable method for children. This study aimed to evaluate the effectiveness of two different doses of melatonin premedication in reducing preoperative anxiety in children. Methods: A double-blind randomized study, carried out after ethical committee approving, and involved 120 children aged 4–10 years, classified as American Society of Anesthesiologists physical status I or II, undergoing elective surgery under general anesthesia in the pediatric surgery department in Bent-Alhuda Teaching Hospital in Al Nasiriya city from July 2023 to the end of January 2024. Participants were randomly assigned into three groups of 40 patients (Groups M04, M02, and Placebo) to receive either oral melatonin 0.4 mg/kg, 0.2 mg/kg, or identical placebo premedication 60 minutes before induction. Anxiety levels were assessed 15 minutes before premedication, 45 minutes after premedication, and during parental separation, while sedation levels were evaluated at three-time points, all after the premedication was administered. Results: The three study groups were comparable in terms of mean age, weight, sex, and duration of anesthesia. Following premedication, the M04 group showed a significant reduction in anxiety levels compared to levels in both M02 and placebo groups, with a statistically significant difference (p > 0.05). In all time points of assessment, the sedation levels in the M04 group were significantly higher than those in both the M02 and placebo groups. In contrast, the difference between the M02 and placebo groups was insignificant (p > 0.05). regarding the hemodynamics; we found the measured hemodynamics were closer to the normal levels in the M04 group while in the other two groups, they were not. Conclusion: Administering oral melatonin at a dose of 0.4 mg/kg appears to be more effective than a dose of 0.2 mg/kg or placebo premedication for reducing preoperative anxiety in children during separation from their parents in the preoperative area.