Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Propranolol.
- Who it may be relevant to
- Registry conditions: Migraine Disorders. Basic parameters: 5 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial
Overview
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.
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.
Primary outcome measures
- Change in Monthly Migraine Attack Frequency [Time frame: Baseline and Months 1, 2, and 3]
- Change in Migraine Pain Severity [Time frame: Baseline and Months 1, 2, and 3]
Secondary outcome measures (1)
- Change in Migraine-Related Disability [Time frame: Baseline and Month 3.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Nishtar Hospital Multan — Multan
Identifiers
NCT: NCT07743255 · NMU1