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Intravenous Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized, Controlled Trial - 21/05/21

Doi : 10.1016/j.annemergmed.2020.08.021 
Aaron J. Ruberto, MD, Marco L.A. Sivilotti, MD, MSc , Savannah Forrester, MD, Andrew K. Hall, MD, MMEd, Frances M. Crawford, MD, Andrew G. Day, MSc
 Department of Emergency Medicine, Queen’s University, Kingston, Ontario, Canada 

Corresponding Author.

Abstract

Study objective

Little is known about the cause or optimal treatment of hyperemesis in habitual cannabis users. Anecdotal evidence supports the use of haloperidol over traditional antiemetics for this newly recognized disorder. We compare haloperidol with ondansetron for cannabis hyperemesis syndrome.

Methods

We randomized cannabis users with active emesis to either haloperidol (with a nested randomization to either 0.05 or 0.1 mg/kg) or ondansetron 8 mg intravenously in a triple-blind fashion. The primary outcome was the reduction from baseline in abdominal pain and nausea (each measured on a 10-cm visual analog scale) at 2 hours after treatment. Although the trial allowed for crossover, the primary analysis used only the first treatment period because few subjects crossed over.

Results

We enrolled 33 subjects, of whom 30 (16 men, aged 29 years [SD 11 years] using 1.5 g/day [SD 0.9 g/day] since age 19 years [SD 2 years]) received at least 1 treatment (haloperidol 13, ondansetron 17). Haloperidol at either dose was superior to ondansetron (difference 2.3 cm [95% confidence interval 0.6 to 4.0 cm]; P=.01), with similar improvements in both pain and nausea, as well as less use of rescue antiemetics (31% versus 59%; difference –28% [95% confidence interval –61% to 13%]) and shorter time to emergency department (ED) departure (3.1 hours [SD 1.7] versus 5.6 hours [SD 4.5]; difference 2.5 hours [95% confidence interval 0.1 to 5.0 hours]; P=.03). There were 2 return visits for acute dystonia, both in the higher-dose haloperidol group.

Conclusion

In this clinical trial, haloperidol was superior to ondansetron for the acute treatment of cannabis-associated hyperemesis. The efficacy of haloperidol over ondansetron provides insight into the pathophysiology of this now common diagnosis in many EDs.

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Plan


 Please see page 614 for the Editor’s Capsule Summary of this article.
 Supervising editor: Richard C. Dart, MD, PhD. Specific detailed information about possible conflict of interest for individual editors is available at editors.
 Author contributions: MLAS conceived the study. AJR, MLAS, and AGD designed the trial. AJR and MLAS supervised the conduct of the trial and data collection, and managed the data, including abstraction, entry, and quality control. All authors promoted recruitment of subjects. AGD provided statistical advice on the study design and analyzed the data, and all authors contributed to the interpretation of the results. AJR and MLAS drafted the article, and all authors contributed substantially to its revision. MLAS takes responsibility for the paper as a whole.
 All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
 Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist.
 Trial registration number: NCT03056482
 A podcast for this article is available at www.annemergmed.com.


© 2020  American College of Emergency Physicians. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 77 - N° 6

P. 613-619 - juin 2021 Retour au numéro
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