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Evaluating the effects of intravenous melatonin for preventing agitation and emergence delirium in children undergoing elective surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying emergence delirium, a condition where children experience confusion, agitation, and distress when waking up from general anesthesia after surgery. The study will test whether melatonin, a substance that helps regulate sleep and wake cycles, can prevent this condition when given through an intravenous injection during surgery.

The study will involve children undergoing planned surgical procedures. During the surgery, participants will receive either melatonin or a placebo through their intravenous line. The medication will be combined with sodium chloride solution, which is commonly used for delivering medications through veins.

The research aims to determine if melatonin can safely prevent agitation and confusion in children as they wake up from anesthesia. The study will also look at how much pain medication children need after surgery and monitor for any side effects of the treatment. This is a carefully controlled study where neither the medical staff nor the patients will know which treatment is being given.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    Your child must be between 1 and 6 years old to participate in this study

    The planned surgery must be elective (planned in advance) and last at least 30 minutes under general anesthesia

  2. Step 2

    During surgery

    Your child will receive either melatonin or a salt solution (sodium chloride) through an intravenous line

    The medication will be given while your child is under general anesthesia

    Neither you nor the medical staff will know which substance your child receives

  3. Step 3

    After surgery monitoring

    Medical staff will observe your child for signs of agitation or confusion after waking up from anesthesia

    The team will monitor and record any unusual behavior or discomfort

    Pain medication use will be documented

  4. Step 4

    Safety assessment

    Medical staff will check for any side effects or unexpected reactions

    All observations will be recorded as part of the study data

  5. Step 5

    Study completion

    The study participation ends after the post-surgery observation period

    Your child's participation helps evaluate if melatonin can prevent agitation after surgery in children

Who can join the trial?

7 criteria

  • Child must be between 1 and 6 years old
  • Child must be scheduled for a planned (elective) surgery that will take at least 30 minutes
  • Surgery must be performed under general anesthesia (medicine that makes the patient completely unconscious during the procedure)
  • Both boys and girls can participate
  • Child must be healthy enough to undergo planned surgery
  • Parent or legal guardian must give consent for the child's participation in the study
  • Child must be scheduled for a non-emergency surgical procedure (one that is planned in advance)

Who cannot join the trial?

13 criteria

  • Children younger than 2 years or older than 18 years of age
  • Known allergy or hypersensitivity (severe allergic reaction) to melatonin or any of its components
  • Children with severe medical conditions affecting the heart, lungs, liver, or kidneys
  • History of sleep disorders or current use of sleep medications
  • Children with neurological disorders (conditions affecting the brain and nervous system)
  • Emergency or unplanned surgical procedures
  • Children taking medications that may interact with melatonin
  • Previous adverse reactions to anesthesia
  • Children with developmental delays or cognitive impairment
  • Inability to obtain informed consent from parents or legal guardians
  • Participation in another clinical trial within the past 30 days
  • Children with diagnosed psychiatric conditions requiring medication
  • Any condition that, in the opinion of the investigator, could compromise the safety of the participant
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Investigated drugs

Melatonin - A naturally occurring hormone that helps regulate sleep-wake cycles. In this trial, it is given intravenously during surgery to help prevent agitation and confusion (emergence delirium) in children after surgery. While melatonin is commonly known as a sleep aid when taken orally, this trial explores its use through direct administration into the bloodstream during surgical procedures to help children have a calmer and more comfortable recovery from anesthesia.

What is already known about the treatment

Melatonin - A naturally occurring hormone that is available as an intravenous medication in clinical trial settings for preventing emergence delirium and postoperative agitation in children undergoing surgery. The medication works by regulating sleep-wake cycles and has calming effects on the central nervous system through interaction with melatonin receptors in the brain. As a pharmacological agent, it belongs to the class of neurohormones and is being studied for its potential to reduce post-surgical behavioral disturbances in pediatric patients, representing a novel approach to managing emergence delirium compared to traditional sedatives.

Investigated diseases

  • Emergence delirium

    A temporary state of mental confusion and distress that occurs when a person wakes up from anesthesia after surgery. It is characterized by disorientation, restlessness, and sometimes agitation during the early recovery period. Patients may experience confusion about their surroundings, have difficulty following commands, or display uncharacteristic behavior. This condition typically develops within the first 30 minutes after emerging from anesthesia. The symptoms usually resolve spontaneously as the effects of anesthesia wear off. This condition is particularly common in children following surgical procedures.

  • Emergence agitation

    A postoperative behavioral disturbance characterized by temporary psychological and physical symptoms that occur during recovery from anesthesia. Patients may experience combative behavior, disorientation, and inability to recognize familiar people. The condition manifests as restlessness, thrashing, crying, or incoherence during the immediate recovery period. It typically begins upon awakening from anesthesia and can last for several minutes to hours. This state is more frequently observed in younger patients, especially children.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-517592-20-00Protocol code20211125Estimated enrolment676 patientsSponsorRigshospitalet

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).