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

  • PDF / 289,874 Bytes
  • 6 Pages / 595.276 x 790.866 pts Page_size
  • 90 Downloads / 201 Views

DOWNLOAD

REPORT


ORIGINAL ARTICLE

Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial V. Pavithra 1 & Devendra Mishra 1

&

Shatrishna Behera 1 & Monica Juneja 1

Received: 28 October 2019 / Accepted: 17 April 2020 # Dr. K C Chaudhuri Foundation 2020

Abstract Objective To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura. Methods 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 Painrelief (≥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. Results 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). Conclusions Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children. Keywords Efficacy . Headache . Pain-relief . Side-effects

Introduction Migraine is a common disorder in children, and is responsible for significantly affecting disability-adjusted life-years (DALY) in the pediatric population [1]. It is the commonest headache among children in India, both in the hospital and the community [2–4]. Management of migraine in children primarily consists of early treatment of an acute attack by an Note: Trial Registration: CTRI/2017/11/010564 Presented at the 19th International Headache Congress, Dublin, 2019. Second prize winner at IJP MD Thesis Competition, 2019. * Devendra Mishra [email protected] 1

Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi 110002, India

appropriate route, prevention of future attacks, and lifestyle modifications [5]. Among the drugs available for treatment of an acute migraine headache in children, paracetamol and ibuprofen are the most commonly used therapies in the Indian set-up. Despit