Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial

To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura.

This randomized-controlled trial was done at the Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6–12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria. The 50 patients (21 females, mean age 9.9 y) consecutively enrolled were randomized by block randomization to two study groups, with one group (n = 25) receiving oral paracetamol (15 mg/kg/dose) and the other group (n = 25) oral ibuprofen (10 mg/kg/dose), at home, during a single episode of acute migraine headache. The study drugs were dispensed in a blinded fashion. Pain-freedom (score of zero in a 0–10 Visual analogue pain scale) and Pain-relief (≥2-point reduction from the baseline) two-hours after the study drug intake were the primary outcomes. Side-effects to the study drugs were actively solicited. Non-parametric tests for paired data were used.

The two groups were similar at baseline. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study. Both pain-freedom (32% vs. 28%, P = 0.77) and pain-relief (80% vs. 80%, P = 0.86) were not significantly different between the Paracetamol and Ibuprofen groups, respectively. Ten (23.2%) children had a side-effect due to the study drug, with no significant difference between the groups (13.6% vs. 33.3%; P = 0.11).

Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.