Clinical Trial

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

Enrolling by Invitation
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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.
Trial Details
NCT Number NCT07743255
Lead Sponsor Nishtar Medical University
Conditions Migraine Disorders
Enrollment 60 participants
Start Date 2026-06-10
Primary Completion 2026-12-10 (estimated)
Study Completion 2026-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-03