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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Clément Le Cornec, Said Lariby, Vivien Brenckmann, Jean Benoit Hardouin, Claude Ecoffey, Marion Le Pottier, Philippe Fradin, Hélène Broch, Amine Kabbaj, Yannick Auffret, Florence Deciron, Céline Longo, François Javaudin, Quentin Le Bastard, Joël Jenvrin, Emmanuel Montassier
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2634-3) contains supplementary material, which is available to authorized users.

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.
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