Clinical trial NCT03236805: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
Official title: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain Management
Keywords: Morphine
Ketamine
Acute pain
prehospital
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.
timeFrame: 30 minutes
Secondary outcomes:
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.
timeFrame: 15 minutes
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.
timeFrame: 45 minutes
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Chateaubriant
country: France
facility: Hospital of Chateaubriant
city: Gonesse
country: France
facility: CH de Gonesse
city: Grenoble
country: France
facility: Grenoble University Hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: Le Mans
country: France
facility: Le Mans University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Quimper
country: France
facility: Quimper Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Nazaire
country: France
facility: Hospital of Saint Nazaire
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Joel JENVRIN, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.