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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03236805
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Management Drug: Ketamine Drug: Morphine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection. [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection. [ Time Frame: 15 minutes ]
  2. Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection. [ Time Frame: 45 minutes ]
  3. Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection. [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236805


Contacts
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Contact: Joel JENVRIN, Doctor +33 2 53 48 21 01 joel.jenvrin@chu-nantes.fr
Contact: Emmanuel MONTASSIER, Doctor +33 2 53 48 20 38 emmanuel.montassier@chu-nantes.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49100
Contact: Marion Le Pottier, Doctor    +33 241353637    marion.lePottier@chu-angers.fr   
University Hospital of Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Michel GALINSKI, Dr       michel.galinski@chu-bordeaux.fr   
Hospital of Chateaubriant Recruiting
Chateaubriant, France, 44146
Contact: Nicolas HOURDIN, Doctor    +33 240558888    nicolas.hourdin@ch-cnp.fr   
CH de Gonesse Recruiting
Gonesse, France, 95500
Contact: Anne-Laurette GUILLERM, PH    +330134532121    anne.guillerm@ch-gonesse.fr   
Grenoble University Hospital Recruiting
Grenoble, France, 38700
Contact: Vivien BRENCKMANN, Doctor    +33 4 76 76 75 75    vbrenckmann@chu-grenoble.fr   
La Roche sur Yon Hospital Recruiting
La Roche sur Yon, France, 85600
Contact: Philippe FRADIN, Doctor    +33 251446161    philippe.fradin@chd-vendee.fr   
Le Mans University Hospital Recruiting
Le Mans, France, 72037
Contact: Florence DECIRON, Doctor    +33 243434343    fdeciron@ch-lemans.fr   
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Joel JENVRIN, Doctor    +33 53 48 21 01    joel.jenvrin@chu-nantes.fr   
Contact: Clement LE CORNEC, Doctor    +33 2 53 48 20 38    clement.lecornec@chu-nantes.fr   
Quimper Hospital Recruiting
Quimper, France, 29107
Contact: Yannick AUFFRET, Doctor    +33 298526109    y.auffret@ch-cornouaille.fr   
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Claude ECOFFEY, Doctor    +33 299284321    Claude.Ecoffey@chu-rennes.fr   
Hospital of Saint Nazaire Recruiting
Saint-Nazaire, France, 44600
Contact: Amine KABBAJ, Doctor    +33 272 27 80 00    a.kabbaj@ch-saintnazaire.fr   
Tours University Hospital Recruiting
Tours, France, 37000
Contact: Said LARIBI, Doctor    +33 2 47 47 90 22    S.LARIBI@chu-tours.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Joel JENVRIN, Doctor Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03236805    
Other Study ID Numbers: RC17_0082
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Morphine
Ketamine
Acute pain
prehospital
Additional relevant MeSH terms:
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Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action