MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research; Sygehus Lillebaelt; University of Copenhagen
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patients aged 1-6 years

• Elective surgical procedure of en axpected duration over 30 minutes in general anesthesia maintained with sevoflurane

Exclusion Criteria:

• Any known allergy or contraindication to study treatment or excipåients

• Current daily medication with melatonin