Does melatonin after tonsillectomy enhance sleep and recovery in children (MATES)?

The study will be a randomized, double-blinded and placebo-controlled trial. Following approval from the treating anaesthetist and voluntary written informed consent by the parent/guardian, the recruited children will be block randomised and assigned to one of the two groups in a 1:1 ratio to receive either a melatonin solution or placebo solution. As part of the study development, the melatonin dosing was discussed with paediatric pain specialists, respiratory specialists and anaesthetists from Perth Children’s Hospital and other Australian centres. A conservative consensus dosing regime was agreed upon. Patients will receive their first dose 30-45 minutes prior to their usual bedtime on the day of surgery and continue on days 1-6 post-operatively (total of 7 doses). Children will receive a dose of 0.1 mg/kg (of ideal body weight) to a maximum of 5 mg of melatonin or placebo suspension at night by mouth for all their post operative doses. As a medical sleeping aid 1-10 mg is considered to be standard. Sedative premedications administered prior to surgery time (midazolam, clonidine, dexmedetomidine and ketamine) will be allowed as deemed appropriate by the treating anaesthetist. There will be active follow up with the families to ensure study adherence. All families are provided with a standard diary to document medication administration following tonsillectomy surgery. Our families will also be provided with a study diary where they will document further information. They will also report this in the study database via survey links sent daily.