Actively Recruiting
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Led by Rigshospitalet, Denmark · Updated on 2025-01-24
400
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
S
Sygehus Lillebaelt
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1-6 years
- Undergoing an elective surgical procedure expected to last at least 30 minutes
- General anesthesia maintained with sevoflurane
You will not qualify if you...
- Known allergy or contraindication to melatonin or any ingredients in the study treatments
- Current daily use of melatonin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
A
Anne Louise B Garioud, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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