Wednesday, September 23, 2020

Melatonin for acute treatment of migraine in children and adolescents

Amy A. Gelfand, Alexandra C. Ross,  Samantha L. Irwin,  Kaitlin A. Greene, William F. Qubty , I. Elaine Allen.  Melatonin for Acute Treatment of Migraine in Children and Adolescents: A Pilot Randomized Trial.  Headache.  First published: 02 September 2020



To determine what dose of melatonin is most effective for treating migraine acutely in children and adolescents. 


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. 


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. 


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. 


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. _________________________________________________________________

From the article:

Pain was also graded on a continuous scale that participants could “X” at any point along a 10-cm line, representing 0-10 pain, which was positioned above the Wong-Baker FACES Pain Rating Scale. The Wong-Baker FACES Pain Rating Scale is a validated visual analog scale for  assessing physical pain in individuals ages 3 and up; the 10-cm line placed above it is a modification…

Neither dose tested hit the primary outcome measure of decreasing mean pain intensity by at least 3 cm at 2 hours, and there was a high drop-out rate in both groups.

Melatonin treatment was safe and well tolerated in this study. Many parents and participants preferred using melatonin to treat their child’s/their migraine compared to other acute treatments tried previously. Napping was predictive of headache benefit, suggesting that facilitating sleep is one of the mechanisms by which melatonin might help migraine acutely.

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