Melatonin for Acute Treatment of Migraine in Children and Adolescents: A Pilot Randomized Trial.
Study Goal
To determine whether a high or low dose of melatonin is more effective for treating acute migraine in children and adolescents.
Results Summary
Both high and low doses of melatonin were associated with pain reduction in pediatric migraine, with higher doses and napping predicting greater benefit. However, the study had a high drop-out rate, and differences between dose groups were not statistically significant.
Population
Children and adolescents aged 4-17 years with episodic migraine.
Effective Dosage
<40 kg: 4 mg (high dose) vs. 1 mg (low dose); ≥40 kg: 8 mg (high dose) vs. 2 mg (low dose).
Duration
Single-dose intervention with outcomes measured at 2 hours.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
high-dose melatonin | decrease | pain intensity | children and adolescents aged 4-17 years with episodic migraine | -2.7 (2.1) cm change at 2 hours | was associated with pain reduction | #1 |
low-dose melatonin | decrease | pain intensity | children and adolescents aged 4-17 years with episodic migraine | -2.3 (2.1) cm change at 2 hours | was associated with pain reduction | #2 |
high-dose melatonin | increase | 2-hour pain-freedom rate | children and adolescents aged 4-17 years with episodic migraine | 41% (7/17) | was associated with | #3 |
low-dose melatonin | increase | 2-hour pain-freedom rate | children and adolescents aged 4-17 years with episodic migraine | 27% (4/15) | was associated with | #4 |
high-dose melatonin | increase | 2-hour pain-relief rate | children and adolescents aged 4-17 years with episodic migraine | 94% (16/17) | was associated with | #5 |
low-dose melatonin | increase | 2-hour pain-relief rate | children and adolescents aged 4-17 years with episodic migraine | 80% (12/15) | was associated with | #6 |
higher mg/kg dose of melatonin | increase | headache benefit | children and adolescents aged 4-17 years with episodic migraine | - | was independently associated with greater headache benefit | #7 |
napping after treatment | increase | headache benefit | children and adolescents aged 4-17 years with episodic migraine | - | was independently associated with greater headache benefit | #8 |
OBJECTIVE: To determine what dose of melatonin is most effective for treating migraine acutely in children and adolescents. BACKGROUND: Acute migraine medications may not work for all patients and may cause side effects. Melatonin is effective for migraine prevention in adults and has been used acutely for procedural pain in children. Our goal was to determine whether a "high" or "low" dose of melatonin is more effective for treating migraine acutely in youth. METHODS: In this pilot, randomized, open-label, single-center, dose-finding trial, children and adolescents aged 4-17 years with episodic migraine were randomized to "high-dose" or "low-dose" dose melatonin (<40 kg: 4 mg vs. 1 mg; ≥40 kg: 8 mg vs. 2 mg). The primary outcome measure was change in mean pain score between time 0 and 2 hours. Secondary outcomes included 2-hour pain-relief and pain-freedom rates. RESULTS: Eighty-four participants (n = 42 per group) were enrolled in this study. Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female. Mean (SD) headache days/month was 5.6 (3.8). Sixty-six (79%) participants provided outcome data and were included in the analyses, n = 24 in the high-dose group and n = 22 in the low-dose group. The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group. Mean (SD) change in pain intensity at 2 hours was -2.7 (2.1) cm in the high-dose group vs. -2.3 (2.1) cm in the low-dose group (p = .581), a difference of 0.4 cm (95% CI: -1.17 to 1.92). Two-hour pain-freedom rate was 41% (7/17) vs. 27% (4/15) in the high-dose vs. low-dose groups (p = .415), and 2-hour pain-relief rate was 94% (16/17) vs. 80% (12/15), (p = .482). There were no serious adverse events. Napping occurred in the majority (67% (14/21) high dose vs. 47% (9/19) low dose). Higher mg/kg dose of melatonin and napping were each independently associated with greater headache benefit. CONCLUSIONS: As an acute treatment for pediatric migraine, both low and high doses of melatonin were associated with pain reduction; however, study drop-out was high. Higher dose and napping after treatment predicted greater benefit.