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

Al-Azhar University

Status: Enrolling

Conditions: Preoperative Anxiety

Treatments: Drug: placebo group; Drug: melatonin (Circadin ®) 0.4 mg/kg; Drug: melatonin (Circadin ®) 0.2 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT06489327

042/2021/Babel

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• ASA more than III
• Drug allergy.
• Gastrointestinal disorders.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

1st group: melatonin 0.2 mg/kg group

Active Comparator group

Description:

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

Treatment:

Drug: melatonin (Circadin ®) 0.2 mg/kg

2nd group: M04 groupmelatonin 0.4 mg/kg group

Active Comparator group

Description:

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

Treatment:

Drug: melatonin (Circadin ®) 0.4 mg/kg

3rd group: placebo group

Placebo Comparator group

Description:

patients will receive oral placebo premedication

Treatment:

Drug: placebo group