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© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Acute pain is a common condition among prehospital patients and prompt management is pivotal. Opioids are the most frequently analgesics used in the prehospital setting. However, opioids are highly addictive, and some patients may develop opioid dependence, even when they are exposed to brief opioid treatments. Therefore, alternative non-opioid analgesia should be developed to manage pain in the prehospital setting. Used at subdissociative doses, ketamine, a noncompetitive N-methyl-D-aspartate and glutamate receptor antagonist, provides analgesic effects accompanied by preservation of protective airway reflexes. In this context, we will carry out a randomized controlled, open-label, multicenter trial to compare a subdissociative dose of ketamine to morphine to provide pain relief in the prehospital setting, in patients with traumatic and non-traumatic pain.

Methods/design

This will be a multicenter, single-blind, randomized controlled trial. Consecutive adults will be enrolled in the prehospital setting if they experience moderate to severe, acute, non-traumatic and traumatic pain, defined as a numeric rating scale score greater or equal to 5. Patients will be randomized to receive ketamine or morphine by intravenous push. The primary outcome will be the between-group difference in mean change in numeric rating scale pain scores measured from the time before administration of the study medication to 30 min later.

Discussion

This upcoming randomized clinical trial was design to assess the efficacy and safety of ketamine, an alternative non-opiate analgesia, to manage non-traumatic and traumatic pain in the prehospital setting. We aim to provide evidence to change prescribing practices to reduce exposition to opioids and the subsequent risk of addiction.

Trial registration

ClinicalTrials.gov, ID: NCT03236805. Registered on 2 August 2017.

Details

Title
Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial
Author
Le Cornec, Clément 1 ; Lariby, Said 2 ; Brenckmann, Vivien 3 ; Hardouin, Jean Benoit 4 ; Ecoffey, Claude 5 ; Le Pottier, Marion 6 ; Fradin, Philippe 7 ; Broch, Hélène 8 ; Kabbaj, Amine 9 ; Auffret, Yannick 10 ; Deciron, Florence 11 ; Longo, Céline 1 ; Javaudin, François 1 ; Le Bastard, Quentin 1 ; Jenvrin, Joël 1 ; Montassier, Emmanuel 1   VIAFID ORCID Logo 

 Nantes University Hospital, Emergency Department, Nantes, France (GRID:grid.277151.7) (ISNI:0000 0004 0472 0371) 
 Tours University Hospital, Emergency Medicine Department, Tours, France (GRID:grid.411167.4) (ISNI:0000 0004 1765 1600) 
 Emergency Department and Mobile Intensive Care Unit, CHU Grenoble Alpes, Grenoble Cedex 09, France (GRID:grid.411167.4) 
 SPHERE U1246, Inserm, université de Nantes-université de Tours, Nantes, France (GRID:grid.457374.6) 
 Department of Anaesthesia-Emergencies-Intensive Care and Internal Medicine and Geriatrics, Hôpital Pontchaillou, Université de Rennes 1, Rennes Cedex, France (GRID:grid.457374.6) 
 Emergency Department, Centre Hospitalier Universitaire Angers, Angers, France (GRID:grid.411147.6) (ISNI:0000 0004 0472 0283) 
 Emergency Department, La Roche sur Yon Hospital, La Roche Sur Yon, France (GRID:grid.411147.6) 
 Emergency Department, Châteaubriant Hospital, Châteaubriant, France (GRID:grid.411147.6) 
 Emergency Department, Saint Nazaire Hospital, Saint Nazaire, France (GRID:grid.411147.6) 
10  Quimper Hospital CHIC, Emergency Department SAMU, Quimper, France (GRID:grid.477730.0) (ISNI:0000 0004 0639 3554) 
11  Emergency Department, Le Mans Hospital, Le Mans, France (GRID:grid.477730.0) 
Pages
260
Publication year
2018
Publication date
Dec 2018
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2795310912
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.