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Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

NCT07743255 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Migraine Disorders

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.

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Shazia Parveen · Nishtar Hospital Multan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-12-10
Completion
2026-12-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743255 on ClinicalTrials.gov