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NCT Number: NCT07743255

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine with Aura Migraine without Aura Nervous System Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital Multan

Multan, Punjab Province, 66000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

Melatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol.

Propranolol

Drug

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 outcomes

  1. 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.

  2. 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

  1. Change in Migraine-Related Disability

    Time frame: Baseline and Month 3.

    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.

Interested in participating?

Enrolling by invitation

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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