Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: melatonin (Circadin ®) 0.2 mg/kg, melatonin (Circadin ®) 0.4 mg/kg, placebo group.
- Who it may be relevant to
- Registry conditions: Preoperative Anxiety. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt, Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
Overview
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.
Interventions
- Drug 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. - 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. - 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.
Primary outcome measures
- preoperative anxiety [Time frame: 24 hours]
Secondary outcome measures (1)
- preoperative sedation [Time frame: 24 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Facualty of Pharmacy, Al Azhar University — Cairo
Iraq · 1 center
- Al-Ayen Univerisity — Madīnat Bābil
Identifiers
NCT: NCT06489327 · 042/2021/Babel