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MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

RecruitingPhase 3Ages 1 Year - 6 YearsAllArash Afshari
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In plain words

What the trial is, and whether it could suit you

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 administ

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 1-6 years * Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia Exclusion Criteria: * Any known allergy or contraindication to study treatment or excipåients * Current daily medication with melatonin
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What it tests

  • Melatonin
  • Isotonic sodium chloride solution
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Where

1 site
Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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