Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
NCT ID: NCT03236805
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
285 participants
INTERVENTIONAL
2017-11-23
2022-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ketamine IV
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
Morphine IV
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Joel JENVRIN, Doctor
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Angers University Hospital
Angers, , France
University Hospital of Bordeaux
Bordeaux, , France
Hospital of Chateaubriant
Châteaubriant, , France
CH de Gonesse
Gonesse, , France
Grenoble University Hospital
Grenoble, , France
La Roche sur Yon Hospital
La Roche-sur-Yon, , France
Le Mans University Hospital
Le Mans, , France
Nantes University Hospital
Nantes, , France
Quimper Hospital
Quimper, , France
Rennes University Hospital
Rennes, , France
Hospital of Saint Nazaire
Saint-Nazaire, , France
Tours University Hospital
Tours, , France
Countries
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References
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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.
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.
Other Identifiers
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RC17_0082
Identifier Type: -
Identifier Source: org_study_id