Abstract
BackgroundAcute 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT03236805. Registered on 2 August 2017.
Highlights
Acute pain is a common condition among prehospital patients and prompt management is pivotal
We aim to provide evidence to change prescribing practices to reduce exposition to opioids and the subsequent risk of addiction
Pain is a common condition among prehospital patients [1]
Summary
Acute pain is a common condition among prehospital patients and prompt management is pivotal. Alternative non-opioid analgesia should be developed to manage pain in the prehospital setting. 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. In Australia, Jennings et al reported that 34.5% of prehospital patients experienced pain, the majority presenting with traumatic or medical etiology (40.1% and 39.1%, respectively). Rapid and efficient management of acute pain is pivotal in the prehospital setting. In France, Galinski et al reported that, overall, 51% of the patients experienced pain relief during prehospital management, and that inadequate pain control is more frequent in patients with traumatic or gynecologic/obstetric pain [3]
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