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REVIEW ARTICLE Symptomatic Treatment of Migraine in Children

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REVIEW ARTICLE Symptomatic Treatment of Migraine in Children REVIEW ARTICLE Symptomatic Treatment of Migraine in Children: A Systematic Review of Medication Trials Le´onie Damen, PhD*; Jacques K. J. Bruijn, MD‡§; Arianne P. Verhagen, PhD*; Marjolein Y. Berger, MD PhD*; Jan Passchier, PhD࿣; and Bart W Koes, PhD* ABSTRACT. Objective. Treatment of pediatric mi- hours after intake than placebo with minor adverse ef- graine includes an individually tailored regimen of both fects. No clear differences in effect were found between nonpharmacologic and pharmacologic measures. The acetaminophen and ibuprofen or nimesulide. mainstay of symptomatic treatment in children with mi- Regarding the nonanalgesic interventions, nasal-spray graine is intermittent oral or suppository analgesics, but sumatriptan, oral sumatriptan, oral rizatriptan, oral dihy- there is no coherent body of evidence on symptomatic droergotamine, intravenous prochlorperazine, and ke- treatment of childhood migraine available. The objective torolac were evaluated. When compared with placebo, of this review is to describe and assess the evidence from nasal-spray sumatriptan (pooled RR: 1.4; 95% CI: 1.2–1.7) randomized and clinical controlled trials concerning the seemed to significantly reduce HAs. We conclude that efficacy and tolerability of symptomatic treatment of mi- there is moderate evidence that nasal-spray sumatriptan graine in children. is more effective in reduction of symptoms than placebo Design. Systematic review according to the standards but with significantly more adverse events. No differ- of the Cochrane Collaboration. ences in effect were found between oral triptans and Methods. Databases were searched from inception to placebo. All medications were well tolerated, but signif- June 2004. Additional reference checking was performed. icantly more adverse events were reported for nasal- Two authors independently selected randomized and spray sumatriptan compared with placebo. controlled trials evaluating the effects of symptomatic We also conclude that there is moderate evidence that treatment in children (<18 years old) with migraine, us- intravenous prochlorperazine is more effective than in- ing headache (HA) clinical improvement as an outcome travenous ketorolac in the reduction of symptoms 1 hour measure. Two authors assessed trial quality indepen- after intake. No differences in effect were found between dently by using the Delphi list, and data were extracted oral dihydroergotamine and placebo. from the original reports by using standardized forms. Conclusions. Acetaminophen, ibuprofen, and nasal- Quantitative and qualitative analysis was conducted ac- spray sumatriptan are all effective symptomatic pharma- cording to type of intervention. cologic treatments for episodes of migraine in children. Results. A total of 10 trials were included in this The new frontier for symptomatic treatment is likely to review, of which 6 studies were considered to be of high be the development of triptan agents for use in children. quality. The number of included participants in each trial Most treatments have only been evaluated in 1 or 2 ranged from 14 to 653, with a total of 1575 patients in- studies, which limits the generalizability of the findings. cluded in this review. Mean dropout rate was 19.8% We strongly recommend performing a large, high- (range: 0–39.1%), and the mean age of participants was quality randomized, controlled trial evaluating different ؎ 11.7 2.2 years (range: 4–18 years). symptomatic medications compared with each other or to All studies used HA diaries to assess outcomes. In placebo treatment. Favorable high-quality studies should most studies, a measure of clinical improvement was be performed and reported according to the CONSORT calculated by using these diaries. Improvement often was statement. Clinical improvement of HA should be used regarded as being clinically relevant when the patients’ as the primary outcome measure, but quality of life, days HA declined by >50%. missed at school, and satisfaction of child or parents Regarding oral analgesic treatment, the effectiveness should also be used as an outcome measure in future of acetaminophen, ibuprofen, and nimesulide were eval- studies. Pediatrics 2005;116:e295–e302. URL: www. uated. When compared with placebo, acetaminophen pediatrics.org/cgi/doi/10.1542/peds.2004-2742; migraine, (relative risk [RR]: 1.5; 95% confidence interval [CI]: 1.0– children, symptomatic treatment, systematic review, clin- 2.1) and ibuprofen (pooled RR: 1.5; 95% CI: 1.2–1.9) sig- ical trials, medication. nificantly reduced HAs. We conclude that there is mod- erate evidence that both acetaminophen and ibuprofen are more effective in reduction of symptoms 1 and 2 ABBREVIATIONS. RCT, randomized, controlled trial; CCT, clin- ical controlled trial; HA, headache; IHS, International Headache Society; RR, relative risk; CI, confidence interval; IV, intravenous. From the Departments of *General Practice, ‡Pediatric Neurology, and ࿣Medical Psychology and Psychotherapy, Erasmus Medical Centre, Rotter- dam, Netherlands; and §Department of Pediatrics, Vlietland Hospital, igraine is an important clinical problem in Vlaardingen, Netherlands. Accepted for publication Feb 15, 2005. school-aged children, with an estimated 1,2 doi:10.1542/peds.2004-2742 Mprevalence of 2.7% to 10%. It is character- No conflict of interest declared. ized by attacks of intense, throbbing, unilateral head Address correspondence to Arianne P. Verhagen, PhD, Department of pain, often accompanied by nausea, vomiting, pho- General Practice, Erasmus Medical Centre, PO Box 1738, 3000 DR, Rotter- 3,4 dam, Netherlands. E-mail: [email protected] tophobia, and phonophobia. PEDIATRICS (ISSN 0031 4005). Copyright © 2005 by the American Acad- Treatment of pediatric migraine includes an indi- emy of Pediatrics. vidually tailored regimen of both nonpharmacologic www.pediatrics.org/cgi/doi/10.1542/peds.2004-2742Downloaded from www.aappublications.org/news byPEDIATRICS guest on October Vol. 1, 2021 116 No. 2 August 2005 e295 and pharmacologic measures. Nonpharmacologic Methodologic Quality and Data Extraction modalities include lifestyle adjustments (ie, sleep hy- Two authors (L.D. and J.K.J.B. or A.P.V.) independently as- giene, dietary adjustment, or exercise program), re- sessed the methodologic quality of the included trials using the assurance, stress management, biofeedback, and Delphi list.8 The Delphi list is a generic criteria list developed by international consensus and consists of (1) randomization, (2) other biobehavioral therapies. Pharmacologic inter- adequate allocation concealment, (3) groups similar at baseline, (4) ventions include the use of symptomatic medication specification of eligibility criteria, (5) blinding of outcome asses- such as analgesics (acetaminophen, ibuprofen), sor, (6) blinding of care provider, (7) blinding of patient, (8) triptans (sumatriptan), and antiemetics (prochlor- presentation of point estimates and measures of variability, and perazine) and the use of prophylactic medication. (9) intention-to-treat analysis. One extra item was added because it was found to be relevant for these studies: (10) withdrawal/ The mainstay of symptomatic treatment in children dropout rate (Ͼ20% or selective dropout) unlikely to cause bias. with migraine is intermittent oral or suppository an- The methodologic criteria were scored as yes (1), no (0), or don’t algesics, but there is no coherent body of evidence on know (0). symptomatic treatment of childhood migraine avail- A quality score of each trial was computed by counting the number of positive scores. Any disagreements were resolved able. through consensus, when possible, or by arbitration of a third Good-quality controlled trials preferably summa- author (J.K.J.B. or A.P.V.). rized in a systematic review form the basis for evi- Data extraction was performed by 1 author (L.D.) and checked dence-based treatment guidelines, which may im- by a second author (A.P.V.). Disagreements were resolved by prove the management and treatment of individual consensus. Extracted information included (if available) demo- graphic data, detailed description of the intervention and control patients. One systematic review on triptans only for (ie, dose given, study duration), outcome measures, and informa- pediatric migraine has been performed.5 Based on 4 tion on adverse effects. randomized, controlled trials (RCTs), they found ef- fectiveness with nasal-spray sumatriptan compared with placebo in acute pediatric migraine, whereas Data Analysis oral sumatriptan and rizatriptan were not clearly We calculated relative risks (RRs) with 95% confidence inter- 5 vals (CIs). We performed an available-case analysis (data re- beneficial. To study adverse events, open-label stud- ported), and if sufficient data were available, we also performed a 5 ies were also included. worst-case analysis (ie, all dropouts are assumed to be nonre- The objective of this review was to describe and sponders). Data are presented as treatment success, indicating that assess the evidence from RCTs and clinical con- aRRϾ 1 represents a better outcome for the first mentioned intervention group. trolled trials (CCTs) concerning the efficacy and tol- In case of a crossover trial, we ideally would like to restrict our erability of symptomatic treatment of migraine in analysis to first-period data only or, in case of a sufficient washout children. period and no carryover effect, data of both periods could be combined. In this review we analyzed the crossover trials as if they were
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