Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Monthly Migraine Attack Frequency
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Monthly Migraine Attack Frequency
Time Frame: Baseline and Months 1, 2, and 3
Monthly migraine attack frequency was defined as the number of migraine attacks occurring during a 30-day period, as recorded by the parent or caregiver in the daily headache diary. Separate attacks were identified by a pain-free interval of at least 24 hours. Change from baseline was calculated by comparing the number of attacks recorded before treatment with the number recorded during follow-up. A greater reduction indicated better preventive efficacy.
Change in Migraine Pain Severity
Time Frame: Baseline and Months 1, 2, and 3
Migraine pain severity was assessed using a 0-10 Visual Analog Scale, where 0 represented no pain and 10 represented the worst possible pain. The parent, caregiver, or child recorded the severity of each migraine attack in the headache diary. The average pain score for each 30-day assessment period was calculated and compared with the baseline value. A greater reduction indicated improvement in migraine severity.
Secondary Outcomes
- Change in Migraine-Related Disability(Baseline and Month 3.)
Investigators
Shazia Parveen
Principal Investigator
Nishtar Medical University