MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Isotonic sodium chloride solution.
- Who it may be relevant to
- Registry conditions: Emergence Delirium. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
Overview
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.
Interventions
- Drug Melatonin
Melatonin for injection 1 mg/mL - Drug Isotonic sodium chloride solution
Sodium chloride 0.9 % for injection
Primary outcome measures
- Incidence of emergence agitation [Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).]
Secondary outcome measures (2)
- Opioid consumption [Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).]
- Non-serious Adverse Events (AE) [Time frame: From enrolment to the trial until 24-hour follow-up.]
Eligibility criteria
Inclusion criteria
- Patients aged 1-6 years
- Elective surgical procedure of en axpected duration of at least 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Department of Anesthesiology, Juliane Marie Center, Rigshospitalet — Copenhagen
Publications
- de Barros Garioud AL, Afshari A, Halgreen LR, Nielsen KO, Andersen LPK. Pharmacokinetics of Intravenous Melatonin in Preschool-Aged Pediatric Surgical Patients. Paediatr Anaesth. 2026 Jun 22. doi: 10.1002/pan.70248. Online ahead of print. PMID 42325096
Identifiers
NCT: NCT05541276 · 20211125 · 2021-006464-24