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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of either sex

age from 4 to 14 years

Patients with American society Anesthesiologist physical status I and II

Patients undergoing elective surgeries

Disqualifiers

ASA more than III

Drug allergy.

Gastrointestinal disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • melatonin (Circadin ®) 0.2 mg/kg

    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.

  • melatonin (Circadin ®) 0.4 mg/kg

    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.

  • placebo group

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: 1st group: melatonin 0.2 mg/kg groupActive comparator 1 intervention
Group B: 2nd group: M04 groupmelatonin 0.4 mg/kg groupActive comparator 1 intervention
Group C: 3rd group: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

preoperative anxiety

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.

Time frame
24 hours

Secondary outcomes

1

preoperative sedation

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.

Time frame
24 hours

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Al-Ayen Iraqi University

Collaborator