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

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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

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE November 23, 2017
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection. [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection. [ Time Frame: 15 minutes ]
  • Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection. [ Time Frame: 45 minutes ]
  • Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection. [ Time Frame: 60 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
Official Title  ICMJE Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pain Management
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine IV
    Intervention: Drug: Ketamine
  • Active Comparator: Morphine IV
    Intervention: Drug: Morphine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2017)
496
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03236805
Other Study ID Numbers  ICMJE RC17_0082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel JENVRIN, Doctor Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP