Actively Recruiting
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
Led by Rigshospitalet, Denmark · Updated on 2025-01-24
400
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
S
Sygehus Lillebaelt
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children aged 1 to 6 years undergoing elective surgeries lasting at least 30 minutes under general anesthesia with sevoflurane. The trial aims to evaluate whether intravenous melatonin given during surgery can prevent postoperative agitation and emergence delirium, which are common behavioral disturbances in children waking from anesthesia. Participants are randomly assigned to receive either a single intravenous dose of melatonin at 0.15 mg/kg approximately 30 minutes before the end of surgery or an equivalent volume of saline as a placebo. The study is double-blind, meaning neither participants nor researchers know which treatment is given. During and after surgery, researchers will monitor children for agitation up to about 4 hours in the recovery room, track opioid use, and check for any non-serious side effects up to 24 hours. The study will assess the safety and effects of melatonin compared to placebo to better understand its potential role in preventing these postoperative behaviors.
CONDITIONS
Brief 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 to 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 its ingredients
- Current daily medication with melatonin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure day
Participants receive a single intravenous injection of melatonin or placebo approximately 30 minutes before the end of their surgical procedure under general anesthesia.
1 visit (in-person on surgery day)
Duration - Up to 24 hours after surgery
Participants are monitored for emergence agitation, opioid consumption, and non-serious adverse events up to 24 hours after surgery.
Approximately 1 follow-up visit or monitoring period within 24 hours
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
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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