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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.12.2024

Trial locations

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.

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 ID:

2024-517592-20-00

Protocol code:

20211125

NCT ID:

NCT05541276

Trial Phase:

Therapeutic confirmatory (Phase III)

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