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ENROLLING BY INVITATION
NCT07743255
NA

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

Sponsor: Nishtar Medical University

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluated whether adding melatonin to propranolol provided better prevention of migraine in children than propranolol alone. The study included 60 children aged 5-15 years with migraine, diagnosed according to the International Classification of Headache Disorders criteria, who attended the Pediatric Outpatient Department of Nishtar Hospital, Multan. Participants were randomly assigned in equal numbers to receive either melatonin 3 mg at bedtime plus propranolol 1 mg/kg/day in two divided doses, or propranolol 1 mg/kg/day alone, for three months. Migraine attacks, pain severity, attack duration, migraine-related disability, use of pain-relieving medicines, treatment adherence, and adverse effects were recorded at baseline and during follow-up visits at one, two, and three months. Parents or caregivers maintained a daily headache and medication diary throughout the treatment period. Blood pressure and pulse rate were also monitored because propranolol may cause low blood pressure or a slow heart rate.

Official title: Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

5 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-10

Completion Date

2026-12-10

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

Melatonin

Melatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol.

DRUG

Propranolol

Propranolol 1 mg/kg/day was administered orally in two equal divided doses, equivalent to 0.5 mg/kg per dose in the morning and evening, for three months.

Locations (1)

Nishtar Hospital Multan

Multan, Punjab Province, Pakistan