Melatonin for Pediatric Emergence Agitation

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2022-12-03

Brief Summary

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efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

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Detailed Description

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Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

39 participant will receive melatonin 0.05 mg/kg

Group Type ACTIVE_COMPARATOR

Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg

Intervention Type DRUG

will be administered 1 hour before arrival to operating room

Sevoflurane

Intervention Type DRUG

for anaesthesia induction 3-8 MAC

2

39 participant will receive melatonin 0.2 mg/kg

Group Type ACTIVE_COMPARATOR

Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg

Intervention Type DRUG

will be administered 1 hour before arrival to operating room

Sevoflurane

Intervention Type DRUG

for anaesthesia induction 3-8 MAC

3

39 participant will receive melatonin 0.4 mg/kg

Group Type ACTIVE_COMPARATOR

Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg

Intervention Type DRUG

will be administered 1 hour before arrival to operating room

Sevoflurane

Intervention Type DRUG

for anaesthesia induction 3-8 MAC

Interventions

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Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg

will be administered 1 hour before arrival to operating room

Intervention Type DRUG

Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg

will be administered 1 hour before arrival to operating room

Intervention Type DRUG

Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg

will be administered 1 hour before arrival to operating room

Intervention Type DRUG

Sevoflurane

for anaesthesia induction 3-8 MAC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I
* scheduled for unilateral inguinal herniorrhaphy
* parents conscent

Exclusion Criteria

* allergy to this study drug
* Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes