Comparison of Nebulized Ketamine to Intravenous Subdissociative Dose Ketamine for Treating Acute Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind, Double-Dummy Controlled Trial - 02/05/24

Doi : 10.1016/j.annemergmed.2024.03.024

Tommy Nguyen, MD ^a, Mo Mai, MD ^a, Amulya Choudhary, MD ^a, Slavic Gitelman, DO ^a, Jefferson Drapkin, MPH ^a,^⁎ , Antonios Likourezos, MA, MPH ^a, Sarah Kabariti, MPH ^a, Rukhsana Hossain, MPH ^a, Karina Kun, PharmD ^b, Ankit Gohel, PharmD ^b, Patrizia Niceforo, PharmD ^b, Michael Silver, MS ^a, Sergey Motov, MD ^a
^a Department of Emergency Medicine Maimonides Medical Center, Brooklyn, NY
^b Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY

^∗Corresponding Author.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Thursday 02 May 2024

Abstract

Study objective

We aimed to assess and compare the analgesic efficacy and adverse effects of intravenous subdissociative-dose ketamine to nebulized ketamine in emergency department (ED) patients with acute painful conditions.

Methods

We conducted a prospective, randomized, double-blind, double-dummy clinical trial in adult patients (ages 18 and older) with a numerical rating scale pain score of ≥5. We randomized subjects to receive either a single dose of 0.3 mg/kg of intravenous (IV) ketamine or 0.75 mg/kg of nebulized ketamine through a breath-actuated nebulizer. Primary outcome was the difference in pain scores on the numerical rating scale between groups at 30 minutes postmedication administration. The secondary outcomes included the need for rescue analgesia, occurrences of adverse events in each group, and the difference in pain scores at 15, 30, 60, 90, and 120 minutes. We calculated a 95% confidence interval (CI) for a mean difference at 30 minutes, with a minimum clinically important difference set at 1.3 points.

Results

We enrolled 150 subjects (75 per group). Mean pain scores through numerical rating scale were 8.2 for both groups at baseline, which decreased to 3.6 and 3.8 at 30 minutes, yielding a mean difference of 0.23 (95% CI −1.32 to 0.857). We observed no clinically concerning changes in vital signs. No serious adverse events occurred in any of the groups throughout the study period.

Conclusion

We found no difference between the administration of IV and nebulized ketamine for the short-term treatment of moderate to severe acute pain in the ED, with both treatments providing a clinically meaningful reduction in pain scores at 30 minutes.

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Plan

Introduction

Background

Goals of This Investigation

Materials and Methods

Study Design and Setting

Selection of Participants

Interventions

Outcome Measures

Primary Data Analysis

Results

Limitations

Discussion

	Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflicts of interest for individual editors is available at editors.
	Author contributions: TN and SM conceived the study, designed the trial, and obtained research funding. SM and AL supervised the conduct of the trial and data collection. TN, MM, AC, and SG undertook recruitment of participating subjects and managed the data, including quality control. JD, AL, and MS provided statistical advice on study design and analyzed the data. TN, JD, RH, and SM drafted the manuscript, and all authors contributed substantially to its revision. SM takes responsibility for the paper as a whole.
	Data sharing statement: The entire deidentified dataset, data dictionary and analytic code for this investigation are available upon request, from the date of article publication by contacting Sergey Motov, MD, at SMotov@maimo.org.
	Authorship: 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). All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The study received grant support from the New York State Empire Clinical Research Investigator Program (ECRIP) and the Maimonides Research and Development Foundation. The authors report no independent disclosures or conflicts of interest.
	Trial registration number: NCT04947085.
	Please see page XX for the Editor’s Capsule Summary of this article.