Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-12

Study Completion Date

2026-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.

In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.

Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

NCT05766436

Anxiety Acute Emergence Agitation

UNKNOWN NA

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

NCT04273035

Perioperative Anxiety Preanesthetic Medication Inhalation Anesthesia +4 more

UNKNOWN PHASE4

Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

NCT04049201

Anxiety

COMPLETED NA

Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

NCT05925283

Anxiety

UNKNOWN PHASE4

Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

NCT06466915

Comparison of the Effects of Propofol and Nasal Dexmedetomidine

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preoperative Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1st group: melatonin 0.2 mg/kg group

patients will receive oral melatonin at a dose of 0.2 mg/kg

Group Type ACTIVE_COMPARATOR

melatonin (Circadin ®) 0.2 mg/kg

Intervention Type DRUG

Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

2nd group: M04 groupmelatonin 0.4 mg/kg group

patients will receive oral melatonin at a dose of 0.4 mg/kg

Group Type ACTIVE_COMPARATOR

melatonin (Circadin ®) 0.4 mg/kg

Intervention Type DRUG

Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

3rd group: placebo group

patients will receive oral placebo premedication

Group Type PLACEBO_COMPARATOR

placebo group

Intervention Type DRUG

Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

melatonin (Circadin ®) 0.2 mg/kg

Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

Intervention Type DRUG

melatonin (Circadin ®) 0.4 mg/kg

Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

Intervention Type DRUG

placebo group

Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of either sex
* age from 4 to 14 years
* Patients with American society Anesthesiologist physical status I and II
* Patients undergoing elective surgeries