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Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety

BACKGROUND: Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of...

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Autores principales: Shimonovich, Shachar, Gigi, Roy, Shapira, Amir, Sarig-Meth, Tal, Nadav, Danielle, Rozenek, Mattan, West, Debra, Halpern, Pinchas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5103427/
https://www.ncbi.nlm.nih.gov/pubmed/27829367
http://dx.doi.org/10.1186/s12873-016-0107-0
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author Shimonovich, Shachar
Gigi, Roy
Shapira, Amir
Sarig-Meth, Tal
Nadav, Danielle
Rozenek, Mattan
West, Debra
Halpern, Pinchas
author_facet Shimonovich, Shachar
Gigi, Roy
Shapira, Amir
Sarig-Meth, Tal
Nadav, Danielle
Rozenek, Mattan
West, Debra
Halpern, Pinchas
author_sort Shimonovich, Shachar
collection PubMed
description BACKGROUND: Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. METHODS: A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18–70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by “time-to-onset” (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. RESULTS: The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. CONCLUSIONS: IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. TRIAL REGISTRATION: Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12873-016-0107-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-51034272016-11-10 Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety Shimonovich, Shachar Gigi, Roy Shapira, Amir Sarig-Meth, Tal Nadav, Danielle Rozenek, Mattan West, Debra Halpern, Pinchas BMC Emerg Med Research Article BACKGROUND: Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. METHODS: A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18–70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by “time-to-onset” (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. RESULTS: The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. CONCLUSIONS: IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. TRIAL REGISTRATION: Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12873-016-0107-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-11-09 /pmc/articles/PMC5103427/ /pubmed/27829367 http://dx.doi.org/10.1186/s12873-016-0107-0 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Shimonovich, Shachar
Gigi, Roy
Shapira, Amir
Sarig-Meth, Tal
Nadav, Danielle
Rozenek, Mattan
West, Debra
Halpern, Pinchas
Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title_full Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title_fullStr Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title_full_unstemmed Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title_short Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
title_sort intranasal ketamine for acute traumatic pain in the emergency department: a prospective, randomized clinical trial of efficacy and safety
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5103427/
https://www.ncbi.nlm.nih.gov/pubmed/27829367
http://dx.doi.org/10.1186/s12873-016-0107-0
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