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

Not Applicable

Recruiting

• Conditions: Preoperative Anxiety
• Interventions: Drug: melatonin (Circadin ®) 0.4 mg/kg; Drug: melatonin (Circadin ®) 0.2 mg/kg; Drug: placebo group

• Registration Number: NCT06489327
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-22
• Study First Submitted QC: 2024-06-28
• Status Verified: 2024-07
• Study First Posted: 2024-07-05
• Study Start: 2024-07-12
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2nd group: M04 groupmelatonin 0.4 mg/kg group	melatonin (Circadin ®) 0.4 mg/kg	patients will receive oral melatonin at a dose of 0.4 mg/kg
1st group: melatonin 0.2 mg/kg group	melatonin (Circadin ®) 0.2 mg/kg	patients will receive oral melatonin at a dose of 0.2 mg/kg
3rd group: placebo group	placebo group	patients will receive oral placebo premedication

Primary Outcome Measures

Name	Time	Method
preoperative anxiety	24 hours	The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.

Secondary Outcome Measures

Name	Time	Method
preoperative sedation	24 hours	The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6.

Trial Locations

Locations (2)

Facualty of Pharmacy, Al Azhar University; 🇪🇬 Cairo, Egypt

Al-Ayen Univerisity; 🇮🇶 Madīnat Bābil, Babel, Iraq