ABSTRACT

Background: Pre-medication with sedatives is the cornerstone of pharmacological therapy for kids having surgery. According to some research, melatonin can additionally reduce the symptoms of anxiety. The primary objective of this study was to compare the effectiveness of two doses of oral melatonin as pre-medication on preoperative anxiety levels of children undergoing surgeries. Methods: In this double-blinded randomized controlled trial, 126 children, aged 4 to 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. The primary outcome was Preoperative anxiety and sedation assessed by the Modified Yale Preoperative Anxiety Scale (mYPAS-SF). The secondary outcome was the child-parent separation Score (CPSS). Results: Both groups were comparable in terms of demographic characteristics and baseline data. The anxiety score for total patients was 36 ± 7.43 points. Among all age groups, there was no statistically significant difference between the two studied groups according to RR (P=0.234) and HR P= (0.178) Before induction of anesthesia. All patients in both groups had normal SPO2 pre-operatively and before the induction of anesthesia. According to the Modified Yale Preoperative Anxiety Score (mYPAS-SF), The mean anxiety score preoperative in M4 and M2 is 36.53 ± 8.25 and 35.47 ± 6.54, respectively, with no statistically significant (p=0.427). Post medication (prior induction of anaesthesia), the mean anxiety score in M4 and M2 was 33.76 ± 12.08 and 39.54 ± 11.92, respectively, with a statistically significant difference (p=0.008). The group’s sedation scores following pre-medication were statistically significant (P = 0.005). However, M 4 group members experienced the greatest minimal sedation (46%) and M 2 group members the least (22.2%). During child-parental separation, 66.7% and 47.6% of the children in groups M4 and M2 were unafraid, cooperative, and asleep. There was a statistically significant variance (P = 0.021). Conclusion: M4 acts significantly better on anxiety levels and child-parent separation with comparable effects on hemodynamic and respiratory parameters and without any case of deep sedation.