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

DOI: https://doi.org/10.1007/s12098-020-03315-x

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

The 50 patients (21 females, mean age 9.9 years) 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 =  5) oral ibupro- fen (10 mg/kg/dose), at home, during a single episode of acute migraine headache. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed

the study.

4.9 Childhood and Adolescent

845

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.

Extended: The 50 patients thus enrolled were randomized by block randomiza- tion to the two study groups, with one group (n = 25) receiving oral paracetamol and the other group (n = 25) oral ibuprofen, at home, during an episode of acute migraine headache.

Introduction It is the commonest headache among children in India, both in the hospital and the community[644–646].

Management of migraine in children primarily consists of early treatment of an acute attack by an appropriate route, prevention of future attacks, and lifestyle mod- ifications [647].

Among the drugs available for treatment of an acute migraine headache in chil- dren, paracetamol and ibuprofen are the most commonly used therapies in the Indian set-up.

As not much information is available on the relative efficacy of first-line analge- sics, paracetamol and ibuprofen in the acute treatment of migraine, the authors com- pared oral forms of both these drugs in acute migraine without aura in children attending a public hospital in India.

Material and Methods From the enrolled children, those with any of the following features were excluded: diagnosed with another co-existent headache disorder; history of vomiting within 30 min of the start of the attack, in the majority of attacks (>50%); and presence of a co-morbid acid peptic disease or any other disorder causing gastritis, which pre- cludes the use of study drugs.

All children with a history of recurrent headache were assessed in the pediatric

neurology clinic including history and clinical examination.

A structured form was used to collect relevant details of history and examination of the patients, containing sections on demographic data, family history, co-morbid- ity, and various headache characteristics.

Data for only the first headache episode after enrollment was used for the study

purposes.

And 2 h post-intervention, using the headache chart, children rated the pain intensity and mentioned the presence or absence of the associated symptoms viz, photophobia, phonophobia, nausea and vomiting.

Results One child in paracetamol group and 3 children in ibuprofen group were lost to fol- low-up; whereas, 2 and 1 children in the two groups, respectively discontinued the study drug on their own (trial deviates).

846

4 Treatment

Pain-freedom was achieved in 15 (34.9%) children at 2 h. The proportion of children achieving pain-freedom was not significantly different between the Paracetamol and Ibuprofen groups (36.4% vs. 33.3%, P = 0.88).

40

(93%) children achieved pain-relief

(including 15 children with

pain-freedom).

Only 10 (23.2%) children had a side-effect ascribed to the study drug.

Discussion This placebo-controlled randomized controlled trial of 43 children with migraine headache at a public hospital in India did not find any difference between oral ibu- profen and oral paracetamol with respect to pain-relief or pain- freedom during an acute attack.

The differences in conclusions of various studies could be due to the varying definitions of pain-relief used, the difference in drug doses used, the age of children, the pain-scale used for outcome assessment, and the type of migraine patients’ eligible.

For drugs used in acute treatment of migraine, the recommended study design by International Headache Society is multi-attack, double-blind, placebo-con- trolled and crossover randomized controlled trial [648], which was not possible due to the lack of time available for completing the study, and the availability of patients.

This hospital-based study showed that both ibuprofen and paracetamol are effec- tive and safe for the acute treatment of pediatric migraine headaches, with minimal side-effects.

Acknowledgement A machine generated summary based on the work of Pavithra, V.; Mishra, Devendra; Behera, Shatrishna; Juneja, Monica. 2020 in The Indian Journal of Pediatrics.

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine