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

N

Nantes University Hospital (NUH)

Status and phase

Terminated
Phase 3

Conditions

Pain Management

Treatments

Drug: Ketamine
Drug: Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT03236805
RC17_0082

Details and patient eligibility

About

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.

Full 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.

Enrollment

285 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

285 participants in 2 patient groups

Ketamine IV
Experimental group
Treatment:
Drug: Ketamine
Morphine IV
Active Comparator group
Treatment:
Drug: Morphine

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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