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

Phase 4

Recruiting

• Conditions: Pain following tonsillectomy surgery; Anaesthesiology - Pain management; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000252516
• Lead Sponsor: Perth Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Children aged 2-16 years
Undergoing elective surgery under general anaesthetic for tonsillectomy +/- adenoidectomy +/- grommets or cautery inferior turbinates
Staying overnight in hospital

Exclusion Criteria

•Currently taking Melatonin
•Known cardiovascular, respiratory or neurological disorders giving an American Society of Anaesthesiologists (ASA) physical status classification III or above status
•Known hypersensitivity to the active substance or to any of the excipients listed
•Language barriers impeding data collection
•Department for Child Protection and Family Support is involved in their care
•Planned admissions to the Paediatric Intensive Care Unit (PICU)
•Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child.
•Day surgery tonsillectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of change in the sleep quality of children undergoing tonsillectomy between the pre-operative assessment (baseline) and the assessments at day 7 and day 14 post-operatively. [Parents of participants will be asked to assess their child’s sleep using the validated Patient Reported Outcomes Information System (PROMIS) Parent Proxy Sleep Disturbance – Short Form 8a” scale. Parents of participants will be asked to answer the PROMIS-8a preoperatively (baseline) and at days 7 (primary endpoint) and 14 post-operatively to assess their child’s sleep quality.];Assessment of post-operative sleep quality of children undergoing tonsillectomy.[Parents of participants will be asked to rate their child’s sleep on a 0 (terrible) to 10 (excellent) scale. Parents of participants will be asked to assess their child’s sleep on the 0-10 scale on days 1 to 7 (primary endpoint) and day 10 and 14 post-operatively. ]