Clinical trial

Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics

NCT05223010

Name

1/2022ANET3-A

Description

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

Trial arms

Trial start

2022-01-30

Estimated PCD

2022-06-02

Trial end

2022-12-03

Status

Completed

Phase

Early phase I

Treatment

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

will be administered 1 hour before arrival to operating room

Arms:

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

will be administered 1 hour before arrival to operating room

Arms:

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

will be administered 1 hour before arrival to operating room

Arms:

Sevoflurane

for anaesthesia induction 3-8 MAC

Arms:

1, 2, 3

Size

117

Primary endpoint

emergence behaviour

5 min, 15 min and 30 min after arrival to recovery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 117, 'type': 'ACTUAL'}}

Updated at

2023-10-12

1 organization

2 products

1 indication

Organization

Product

Indication

Product