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Tsze DS, Lubell TR, Carter RC, et al. Intranasal Ketorolac versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Clinical Trial. Acad Emerg Med. 2021;doi: 10.1111/acem.14422.
Tsze, D. S., Lubell, T. R., Carter, R. C., Chernick, L. S., DePeter, K. C., McLaren, S. H., Kwok, M. Y., Roskind, C. G., Gonzalez, A. E., Fan, W., Babineau, S. E., Friedman, B. W., & Dayan, P. S. (2021). Intranasal Ketorolac versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Clinical Trial. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, . https://doi.org/10.1111/acem.14422
Tsze, Daniel S, et al. "Intranasal Ketorolac versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Clinical Trial." Academic emergency medicine : official journal of the Society for Academic Emergency Medicine vol. (2021). doi: https://doi.org/10.1111/acem.14422
Tsze DS, Lubell TR, Carter RC, Chernick LS, DePeter KC, McLaren SH, Kwok MY, Roskind CG, Gonzalez AE, Fan W, Babineau SE, Friedman BW, Dayan PS. Intranasal Ketorolac versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Clinical Trial. Acad Emerg Med. 2021 Nov 25; doi: 10.1111/acem.14422. Epub 2021 Nov 25. PMID: 34822214.
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Acad Emerg Med. 2021 Nov 25; doi: 10.1111/acem.14422. Epub 2021 Nov 25.

Intranasal Ketorolac versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Clinical Trial.

Academic emergency medicine : official journal of the Society for Academic Emergency Medicine

Daniel S Tsze, Tamar R Lubell, Robert C Carter, Lauren S Chernick, Kerrin C DePeter, Son H McLaren, Maria Y Kwok, Cindy G Roskind, Ariana E Gonzalez, Weijia Fan, Shannon E Babineau, Benjamin W Friedman, Peter S Dayan

Affiliations

  1. Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA.
  2. Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
  3. Departments of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University, Morristown, NJ, USA.
  4. Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.

PMID: 34822214 DOI: 10.1111/acem.14422

Abstract

BACKGROUND: Intravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time-consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle-free and easier to administer. We aimed to determine whether intranasal ketorolac is non-inferior to intravenous ketorolac for reducing pain in children with migraine headaches.

METHODS: We conducted a randomized double-blind non-inferiority clinical trial. Children aged 8-17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 minutes after administration measured using the Faces Pain Scale-Revised (scored 0-10). Non-inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain; ancillary emergency department outcomes (e.g. receipt of rescue medications, headache relief, headache freedom, percentage improvement); 24-hour follow-up outcomes; functional disability; and adverse events.

RESULTS: Fifty-nine children were enrolled. We analyzed 27 children who received intranasal ketorolac and 29 who received intravenous ketorolac. The difference in mean pain reduction at 60 minutes between groups was 0.2 (95% CI -0.9, 1.3), with the upper limit of the 95% CI being less than the non-inferiority margin. There were no statistical differences between groups for secondary outcomes.

CONCLUSIONS: Intranasal ketorolac was non-inferior to intravenous ketorolac for reducing migraine headache pain in the emergency department.

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