Study Stopped
285 patients have recruited instead on 496 but we don't want to continue to prolonge the study. Analysis will be performed on the data we have.
Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
KETAMORPH
1 other identifier
interventional
285
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2017
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2022
CompletedDecember 21, 2022
December 1, 2022
5 years
July 17, 2017
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.
30 minutes
Secondary Outcomes (3)
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
Study Arms (2)
Ketamine IV
EXPERIMENTALMorphine IV
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- older than 18 years old
- prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Angers University Hospital
Angers, 49100, France
University Hospital of Bordeaux
Bordeaux, 33000, France
Hospital of Chateaubriant
Châteaubriant, 44146, France
CH de Gonesse
Gonesse, 95500, France
Grenoble University Hospital
Grenoble, 38700, France
La Roche sur Yon Hospital
La Roche-sur-Yon, 85600, France
Le Mans University Hospital
Le Mans, 72037, France
Nantes University Hospital
Nantes, 44093, France
Quimper Hospital
Quimper, 29107, France
Rennes University Hospital
Rennes, 35000, France
Hospital of Saint Nazaire
Saint-Nazaire, 44600, France
Tours University Hospital
Tours, 37000, France
Related Publications (2)
Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, Janiere C, Brenckmann V, Guillerm A, Deciron F, Kabbaj A, Jenvrin J, Pere M, Montassier E. Ketamine Compared With Morphine for Out-of-Hospital Analgesia for Patients With Traumatic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352844. doi: 10.1001/jamanetworkopen.2023.52844.
PMID: 38285446DERIVEDLe 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.
PMID: 29716637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel JENVRIN, Doctor
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
August 2, 2017
Study Start
November 23, 2017
Primary Completion
November 26, 2022
Study Completion
November 26, 2022
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share