Comparison of Nebulized Ketamine at Three Different Dosing Regimens for Treating Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind Clinical Trial - 18/11/21
, Mahlaqa Butt, MPH a, Rukhsana Hossain, MPH a, Sarah Kabariti, MPH a, Antonios Likourezos, MA, MPH a, Ankit Gohel, PharmD b, Patrizia Favale, PharmD b, Michael Silver, MS a, John Marshall, MD a, Sergey Motov, MD aAbstract |
Study objective |
We aimed to assess and compare the analgesic efficacies and adverse effects of ketamine administered through a breath-actuated nebulizer at 3 different dosing regimens for emergency department patients presenting with acute and chronic painful conditions.
Methods |
This was a prospective, randomized, double-blinded trial comparing 3 doses of nebulized ketamine (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg) administered through breath-actuated nebulizer in adult emergency department patients aged 18 years and older with moderate to severe acute and chronic pain. The primary outcome included the difference in pain scores on an 11-point numeric rating scale between all 3 groups at 30 minutes. Secondary outcomes included the need for rescue analgesia (additional doses of nebulized ketamine or intravenous morphine) and adverse events in each group at 30 and 60 minutes.
Results |
We enrolled 120 subjects (40 per group). The difference in mean pain scores at 30 minutes between the 0.75 mg/kg and 1 mg/kg groups was 0.25 (95% confidence interval [CI] 1.28 to 1.78); between the 1 mg/kg and 1.5 mg/kg groups was −0.225 (95% CI −1.76 to 1.31); and between the 0.75 mg/kg and 1.5 mg/kg groups was 0.025 (95% CI −1.51 to 1.56). No clinically concerning changes in vital signs occurred. No serious adverse events occurred in any of the groups.
Conclusion |
We found no difference between all 3 doses of ketamine administered through breath-actuated nebulizer for short-term treatment of moderate to severe pain in the emergency department.
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| Please see page 780 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: DD and SM conceived the study, designed the trial, and obtained research funding. SM, AL, and JM supervised the conduct of the trial and data collection. SM, DD, JD, CF, AD, RH, SK, and MB undertook recruitment of participating subjects and managed the data, including quality control. AL and MS provided statistical advice on study design and analyzed the data. JD, DD, and SM drafted the manuscript, and all authors contributed substantially to its revision. SM takes responsibility for the paper as a whole. |
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| All authors attest to meeting the 4 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. |
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| 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. This study was funded by Maimonides Research and Development Foundation and New York State Empire Clinical Research Investigator Program (ECRIP) grants. |
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| Trial registration number: NCT03909607 |
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Vol 78 - N° 6
P. 779-787 - décembre 2021 Retour au numéro
Article précédent
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