Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia (KETAMORPH)

Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial

This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.

Study Overview

• Status: Terminated
• Conditions: Pain Management
• Intervention / Treatment: Drug: Ketamine; Drug: Morphine

Detailed Description

This study is designed to evaluate if ketamine alone is non inferior to morphine alone for prehospital analgesia. Numeric rating scale pain scores will be compared between recipients of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at hospital admission.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Angers University Hospital
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux
  • Chateaubriant, France, 44146
    • Hospital of Chateaubriant
  • Gonesse, France, 95500
    • CH de Gonesse
  • Grenoble, France, 38700
    • Grenoble University Hospital
  • La Roche sur Yon, France, 85600
    • La Roche Sur Yon Hospital
  • Le Mans, France, 72037
    • Le Mans University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Quimper, France, 29107
    • Quimper Hospital
  • Rennes, France, 35000
    • Rennes University hospital
  • Saint-Nazaire, France, 44600
    • Hospital of Saint Nazaire
  • Tours, France, 37000
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• older than 18 years old
• prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5

Exclusion Criteria:

• unstable vital signs (systolic blood pressure <90 or >200 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min)
• pregnancy
• breast-feeding
• altered mental status
• unable to give numeric rating scale scores
• allergy to morphine or ketamine
• acute pulmonary edema
• acute coronary syndrome
• renal or hepatic insufficiency
• patient who received morphine for the same acute pain
• acute psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine IV	Drug: Ketamine; Initial bolus of 20 mg (around 0.3 mg per kg) followed by bolus of 10 mg every 5 minutes as reported by the recommandations of experts of the french society of urgency care
Active Comparator: Morphine IV	Drug: Morphine; Bolus of 2 mg (patient with weight under 60 kgs) or bolus of 3 mg (patient with weight above 60 kgs) every 5 minutes as reported by the recommandations of experts of the french society of urgency care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.	15 minutes
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.	45 minutes
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.	60 minutes

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Joel JENVRIN, Doctor, Nantes University Hospital

Publications and helpful links

General Publications

• Le Cornec C, Lariby S, Brenckmann V, Hardouin JB, Ecoffey C, Le Pottier M, Fradin P, Broch H, Kabbaj A, Auffret Y, Deciron F, Longo C, Javaudin F, Le Bastard Q, Jenvrin J, Montassier E. Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):260. doi: 10.1186/s13063-018-2634-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): November 26, 2022
• Study Completion (Actual): November 26, 2022

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Ketamine; Morphine; Acute pain; prehospital
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: RC17_0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No