Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

Enrolling by invitation · Not applicable

Conditions studied: Migraine Disorders

In brief

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.

Key facts

Study ID

NCT07743255

Run by

Nishtar Medical University

People needed

60

Starts

2026-06-10

Expected to finish

2026-12-10

Last updated by the study team

2026-08-03

Who can join

Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 5 to 15 years.
• Both male or female.
• Confirmed diagnosis of migraine (with or without aura) based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
• Patients with a PEDMIDAS score ≥11, indicating moderate to severe migraine-related disability.

You may not qualify if…

• Presence of chronic medical conditions affecting the central nervous system, such as epilepsy, neurodegenerative diseases, or brain tumors.
• Current use of prophylactic migraine medications (other than those being evaluated in the study) or recent discontinuation within the last four weeks.
• Patients with diagnosed primary sleep disorders not related to migraine.
• Known allergy or hypersensitivity to melatonin, propranolol, or any related medication used in the study.

Where it is running

• Nishtar Hospital Multan — Multan, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.