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IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial

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Abstract

Background

Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac.

Methods

We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0–3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy.

Results

A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported.

Conclusion

In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding.

Trial registration

Clinicaltrials.gov: NCT # 02664116, Titled “IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine”. Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1

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Data availability

We confirm that the datasets during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Abbreviations

ED:

emergency department

IM:

intramuscular

IV:

intravenous

NSAID:

non-steroidal anti-inflammatory drug

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Acknowledgments

We would like to acknowledge Crystal Serneo for her contribution as research coordinator.

Funding

Funding and supply of study drugs was provided by the sponsor, Depomed Inc.

Author information

Authors and Affiliations

  1. Dalessio Headache Center Scripps Clinic Division of Neurology, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA

    Emily Rubenstein Engel

  2. Scripps Green Hospital, SCMG Hospitalists, 10666 N. Torrey Pines Rd, La Jolla, CA, 92037, USA

    Joshua Cheng

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  1. Emily Rubenstein Engel
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Contributions

We confirm that the individual contributions of the authors are as follows. EE designed the study protocol, analyzed and interpreted the patient data regarding patient characteristics, migraine pain severity, secondary endpoints, and adverse events, and was a major contributor in writing the manuscript. JC provided edits and some post-enrollment analysis.

Corresponding author

Correspondence to Emily Rubenstein Engel.

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Ethics approval and consent to participate

We confirm that any aspect of the work covered in this manuscript that has involved either experimental animals or human patients has been conducted with the ethical approval of all relevant bodies and that such approvals are acknowledged within the manuscript.

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We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us.

We confirm that we have given due consideration to the protection of intellectual property associated with this work and that there are no impediments to publication, including the timing of publication, with respect to intellectual property. In so doing, we confirm that we have followed the regulations of our institutions concerning intellectual property.

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The authors declare that they have no competing interests.

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Engel, E.R., Cheng, J. IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial. Neurol Sci 41, 537–542 (2020). https://doi.org/10.1007/s10072-019-04157-y

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  • DOI: https://doi.org/10.1007/s10072-019-04157-y

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