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October 23, 2017
43031.541667 - 43031.625
Room Exhibit Hall B2 - Area E
A Longitudinal Evaluation of the Effectiveness of Botox® in Pediatric Patients Experiencing Migraines: A Five-Year Retrospective Study
Michael-David Calderon, B.S., Wei Der Wu, B.S., Michael Ma, B.S., Joseph De Los Santos, B.S., Cecilia Canales, M.P.H., Joseph B. Rinehart, M.D., Shalini Shah, M.D.
UC Irvine Health, Orange, California, United States
Disclosures: M. Calderon: None. W. Wu: None. M. Ma: None. J. De Los Santos: None. C. Canales: None. J.B. Rinehart: None. S. Shah: None.
INTRODUCTION: While most chronic pain conditions are manageable, migraine pain can be devastating. Recently, onabotulinumtoxinA was approved for the prophylaxis of migraine symptoms by the US Food and Drug Administration (FDA), which has dramatically altered the way pain physicians approach migraine pain. Unfortunately, most adults who suffer with migraines have their first headache during childhood or adolescence [1].  Although it appears that many preventative agents are safe in children, none are currently FDA-approved. As a result, despite experiencing significant disability, the vast majority of children who present to their physician with migraine headache do not receive prophylactic therapy [2].

OBJECTIVES: Primary outcomes: change in pain intensity, frequency, duration of benefit from the onabotulinumtoxinA therapy in pediatric migraine population aged 8-17.

Secondary outcomes: functionality, disability, adverse events, opioid consumption, concomitant medication use, ED visits, hospitalizations

MATERIALS/METHODS: We performed a retrospective chart review (IRB HS# 2016-3115) on pediatric patients aged 8-17 who received OnabotulinumtoxinA for the treatment of chronic migraine. The criteria used for data extraction included: (1) ICD9/10 codes for migraine; (2) Patients aged 8-17 on date of visit; (3) Visits between 1/1/2012 and 3/16/2017; (4) Patients seen by Principal Investigator.

STATISTICAL ANALYSIS: Manual review of the initial data query identified patients who received onabotulinumtoxinA injections for the treatment of migraines. Statistical analysis was completed using commercially available software (SPSS). Due to the study’s sample size, descriptive statistics using medians and nonparametric testing using Wilcoxon Signed-Ranks test were used for inferential analysis.

RESULTS: Data review showed a total of 10 patients receiving Botox for chronic migraine across 35 injections. One patient was lost to follow-up so their primary outcome data was not available. There was a statistically significant change from pre-injection to post-injection in migraine intensity (10pt VAS score), frequency, and duration of migraine (Table 1). We found no statistically significant change in concomitant medications and oral morphine equivalency (although clinically relevant decrease noted).

DISCUSSION/CONCLUSION: Over a five year period, based on our retrospective review, we found that there was no loss in efficacy with subsequent injections of Botox in pediatric patients with chronic migraine. While the results of this retrospective study are encouraging, there is a possibility of the placebo-effect suggesting that further studies need to be performed for validity.

LIMITATIONS: Possible limitation of this study was the transition to Electronic Medical Records. Since 2012, the institution moved from paper charts to dictations, and eventually Allscripts Electronic Health Record. Some subjects may have been lost in the original data query contributing to a small sample size and made extraction of endpoint data more cumbersome. To verify that onabotulinumtoxinA is truly an effective modality for treating migraines in

pediatric patients, prospective studies with a robust study design should be performed to minimize cofounders.

Table 1: Data reported as medians was due to right-skewed distribution.*One patient had four prior hospital admissions and four patients had one prior admission. Treatment adjustments were made to the injection pattern in response to the patients’ ongoing symptoms and possible injection side effects.
Figure 1

Copyright © 2017 American Society of Anesthesiologists