Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
McLean SA, Maio RF, Domeier RM. The epidemiology of pain in the prehospital setting. Prehospital Emerg. Care. 2002;6:402–5.CrossRef
2.
Jennings PA, Cameron P, Bernard S. Epidemiology of prehospital pain: an opportunity for improvement. Emerg Med J. 2011;28:530–1.CrossRefPubMed
3.
Galinski M, Ruscev M, Gonzalez G, Kavas J, Ameur L, Biens D, et al. Prevalence and management of acute pain in prehospital emergency medicine. Prehospital Emerg. Care. 2010;14:334–9.CrossRef
4.
Murphy AP, Hughes M, McCoy S, Crispino G, Wakai A, O’Sullivan R. Intranasal fentanyl for the prehospital management of acute pain in children. Eur J Emerg Med. 2017;24:450–4.CrossRefPubMed
5.
Bohnert ASB, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305:1315–21.CrossRefPubMed
6.
Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. J Hosp Med. 2014;9:73–81.CrossRefPubMed
7.
Brennan MJ, Stanos S. Strategies to optimize pain management with opioids while minimizing risk of abuse. PM R. 2010;2:544–58.CrossRefPubMed
8.
Chang AK, Bijur PE, Napolitano A, Lupow J, Gallagher EJ. Two milligrams i.v. hydromorphone is efficacious for treating pain but is associated with oxygen desaturation. J Opioid Manag. 2009;5:75–80.CrossRefPubMed
9.
Motov S, Rosenbaum S, Vilke GM, Nakajima Y. Is there a role for intravenous subdissociative-dose ketamine administered as an adjunct to opioids or as a single agent for acute pain management in the emergency department? J Emerg Med. 2016;51:752–7.CrossRefPubMed
10.
Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, et al. Opioid complications and side effects. Pain Physician. 2008;11:S105–20.PubMed
11.
Butler MM, Ancona RM, Beauchamp GA, Yamin CK, Winstanley EL, Hart KW, et al. Emergency department prescription opioids as an initial exposure preceding addiction. Ann Emerg Med. 2016;68:202–8.CrossRefPubMedPubMedCentral
12.
Guirimand F, Dupont X, Brasseur L, Chauvin M, Bouhassira D. The effects of ketamine on the temporal summation (wind-up) of the R(III) nociceptive flexion reflex and pain in humans. Anesth Analg. 2000;90:408–14.PubMed
13.
Schmid J, Tortorano AM, Jones G, Lazzarini C, Zhang N, Bendall MJ, et al. Increased mortality in young candidemia patients associated with presence of a Candida albicans general-purpose genotype. J Clin Microbiol. 2011;49:3250–6.CrossRefPubMedPubMedCentral
14.
Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, et al. Intravenous subdissociative-dose ketamine versus morphine for analgesia in the emergency department: a randomized controlled trial. Ann Emerg Med. 2015;66:222–229.e1.CrossRefPubMed
15.
Svenson JE, Abernathy MK. Ketamine for prehospital use: new look at an old drug. Am J Emerg Med. 2007;25:977–80.CrossRefPubMed
16.
Galinski M, Dolveck F, Combes X, Limoges V, Smaïl N, Pommier V, et al. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007;25:385–90.CrossRefPubMed
17.
Smith DC, Mader TJ, Smithline HA. Low dose intravenous ketamine as an analgesic: a pilot study using an experimental model of acute pain. Am J Emerg Med. 2001;19:531–2.CrossRefPubMed
18.
Losvik OK, Murad MK, Skjerve E, Husum H. Ketamine for prehospital trauma analgesia in a low-resource rural trauma system: a retrospective comparative study of ketamine and opioid analgesia in a ten-year cohort in Iraq. Scand J Trauma Resusc Emerg Med. 2015;23:94.CrossRefPubMedPubMedCentral
19.
Tran KP, Nguyen Q, Truong XN, Le V, Le VP, Mai N, et al. A comparison of ketamine and morphine analgesia in prehospital trauma care: a cluster randomized clinical trial in rural Quang Tri province, Vietnam. Prehospital Emerg Care. 2014;18:257–64.CrossRef
20.
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32.CrossRefPubMedPubMedCentral
21.
22.
Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, et al. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009;374:293–300.CrossRefPubMed
23.
Société française d’anesthésie et de réanimation (SFAR), Société française de médecine d’urgence, Vivien B, Adnet F, Bounes V, Chéron G, et al. Sedation and analgesia in the emergency context. Ann Fr Anesth Reanim. 2010;29:934–49.CrossRef
24.
Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: a randomized clinical trial. JAMA. 2017;318:1661–7.CrossRefPubMed
25.
Chang AK, Bijur PE, Holden L, Gallagher EJ. Comparative analgesic efficacy of oxycodone/acetaminophen versus hydrocodone/acetaminophen for short-term pain management in adults following ED discharge. Acad Emerg Med. 2015;22:1254–60.CrossRefPubMed
26.
Chang AK, Bijur PE, Munjal KG, John GE. Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge. Acad Emerg Med. 2014;21:227–35.CrossRefPubMed
27.
28.
Jennings PA, Cameron P, Bernard S. Ketamine as an analgesic in the pre-hospital setting: a systematic review. Acta Anaesthesiol Scand. 2011;55:638–43.CrossRefPubMed
Metadata
Title
Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2634-3

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial

Research

Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial

Study protocol

Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial

Study protocol

Efficacy and safety of Ding-Kun-Dan for female infertility patients with predicted poor ovarian response undergoing in vitro fertilization/intracytoplasmic sperm injection: study protocol for a randomized controlled trial

Study protocol

Total thyroidectomy (Tx) versus thionamides (antithyroid drugs) in patients with moderate-to-severe Graves’ ophthalmopathy – a 1-year follow-up: study protocol for a randomized controlled trial

Study protocol

Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial