Melatonin Added to Propranolol for Migraine Prevention in Children
Tests melatonin with propranolol to prevent migraine in children aged 5 to 15.
Plain-language title generated from the registry record
Registry title: Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine
Key facts
- Where
- Multan, PakistanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 15 years old?
Source: NCT07743255, who can take part
Where in Pakistan
- Nishtar Hospital MultanMultan, PakistanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nishtar Medical University
- Trial code
- NCT07743255
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial
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.
Inclusion: 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.
Exclusion: Current use of prophylactic migraine medications (other than those being evaluated in the study) or recent discontinuation within the last four weeks; Presence of chronic medical conditions affecting the central nervous system, such as epilepsy, neurodegenerative diseases, or brain tumors; 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.