MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 6
Healthy Volunteers: f
View:

• Patients aged 1-6 years

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

Locations
Other Locations
Denmark
Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Anne Louise B Garioud, MD
anne.louise.de.barros.garioud@regionh.dk
+4535456243
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 400
Treatments
Experimental: Melatonin
Participants receive melatonin solution for injection 1 mg/mL in a dosage of 0.15 mg/kg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure.
Placebo_comparator: Placebo
Participants receive isotonic sodium chloride (9mg/mL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight.
Related Therapeutic Areas
Sponsors
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen, Sygehus Lillebaelt
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov