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 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.
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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18:459–80.
Mishra D, Sharma A, Juneja M, Singh K. Profile of pediatric headache at a public hospital in India. Indian Pediatr. 2013;50:775–8.
Gupta R, Bhatia MS, Dahiya D, et al. Recurrent headache in Indian adolescents. Indian J Pediatr. 2009;76:733–7.
Shivpuri D, Rajesh MS, Jain D. Prevalence and characteristics of migraine among adolescents: a questionnaire survey. Indian Pediatr. 2003;40:665–9.
Oskoui M, Pringsheim T, Holler-Managan Y, et al. Practice guideline update summary: acute treatment of migraine in children and adolescents. Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2019;93:487–99.
Evers S, Rahmann A, Kraemer C, et al. Treatment of childhood migraine attacks with oral zolmitriptan and ibuprofen. Neurology. 2006;67:497–9.
Lewis DW, Kellstein D, Dahl G, et al. Children's ibuprofen suspension for the acute treatment of pediatric migraine. Headache. 2002;42:780–6.
Hämäläinen ML, Hoppu K, Valkeila E. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo controlled, crossover study. Neurology. 1997;48:103–7.
Richer L, Billinghurst L, Linsdell MA, et al. Drugs for the acute treatment of migraine in children and adolescents. Cochrane Database Syst Rev. 2016;4:CD005220.
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2013;33:629–808.
Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–9.
Silver S, Gano D, Gerretsen P. Acute treatment of paediatric migraine: a meta-analysis of efficacy. J Paediatr Child Health. 2008;44:3–9.
Damen L, Bruijn JKJ, Verhagen AP, Berger MY, Passchier J, Koes BW. Symptomatic treatment of migraine in children: a systematic review of medication trials. Pediatrics. 2005;116:e295–302.
Tfelt-Hansen P, Pascual J, Ramadan N, et al; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012;32:6–38.
Author information
Authors and Affiliations
Contributions
DM conceptualized and planned the study, did the statistical analysis, finalized the manuscript, and would be the guarantor. VP assisted in planning the study and statistical analysis, evaluated the patients, carried out follow-up and assessed the outcomes. MJ provided important intellectual inputs in planning and conduct of the study, and assisted in manuscript preparation. SB assisted in planning, randomization, outcome assessment and data analysis. Both VP and SB prepared the initial draft of the manuscript. All authors approved the final manuscript.
Corresponding author
Ethics declarations
Ethical Statement
Study was started after IEC clearance, and all patients were enrolled after informed written consent and assent (where applicable).
Conflict of Interest
None.
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Pavithra, V., Mishra, D., Behera, S. et al. Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial. Indian J Pediatr 87, 781–786 (2020). https://doi.org/10.1007/s12098-020-03315-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12098-020-03315-x