Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

N/AEnrolling By InvitationNCT07743255

Nishtar Medical University60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine Disorders

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

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.

Time frame: Baseline and Months 1, 2, and 3

Change in Migraine Pain Severity

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.

Time frame: Baseline and Months 1, 2, and 3

Secondary Outcomes

Change in Migraine-Related Disability

Migraine-related disability was assessed using the Pediatric Migraine Disability Assessment questionnaire. The total score was calculated from six questions evaluating missed or impaired school, home, social, and recreational activities during the preceding three months. Scores were categorized as minimal disability, 0-10; mild disability, 11-30; moderate disability, 31-50; and severe disability, greater than 50. A lower score indicated less migraine-related disability.

Time frame: Baseline and Month 3.