A prospective randomized study to know the effect of premedication with oral melatonin vs oral midazolam on emergence delirium in children undergoing general anesthesia

This prospective, randomized, comparative study will be conducted on children aged 3-12 years scheduled for elective or emergency surgeries requiring general anesthesia. Patients will be grouped into two groups by simple random method (n=55).

Approximately 30-40 minutes prior to induction of anesthesia, oral premedication will be given to patients in each group, Group A (n=55, Melatonin 0.5mg/kg) and Group B (n=55, Midazolam 0.5mg/kg) by the anesthesiologist (not included in the study) who will prepare the drug according to the code generated by the computer in the preoperative holding area. The coded drugs will be administered by separate anesthetist who will only know the coded number and not the drug given. The patients will be monitored of noninvasive blood pressure, heart rate, respiratory rate, and SpO2. Anxiety and sedation scores will be assessed just prior to administration and at 15 min and 30 min after the drug administration.

In the operating room, intravenous access will be secured and then general anaesthesia will be induced with inj. Fentanyl 2mcg/kg IV, inj. Propofol 2mg/kg IV and inj rocuronium 0.5mg/kg IV. Airway will be secured with intubation with endotracheal tube and anaesthesia will be maintained with sevoflurane (1.2-1.5 MAC) and Air: oxygen (50:50) and intermittent inj.rocuronium 0.1mg/kg IV. Towards the end of the surgery, Inj. Paracetamol 10mg/kg IV and inj. Ondansatron 0.1mg/kg IV will be given. Patients will be reversed prior to completion of the surgery with inj. Neostigmine 0.05mg/kg IV and inj. Glycopyrrolate 0.01mg/kg IV. Once patient is extubated, patient is transferred to PACU where patient will be monitored for the vitals. Anxiety, sedation and emergence delirium scores will be noted immediately on receiving in the PACU and the after 15mins and 30mins. Any side-effects will also be noted and will be treated immediately.