Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia

Phase 3

Terminated

• Conditions: Pain Management
• Interventions: Drug: Ketamine; Drug: Morphine

• Registration Number: NCT03236805
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Start: 2017-11-23
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 285

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine IV	Ketamine	-
Morphine IV	Morphine	-

Primary Outcome Measures

Name	Time	Method
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.	30 minutes

Secondary Outcome Measures

Name	Time	Method
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.	15 minutes
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.	45 minutes
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.	60 minutes

Trial Locations

Locations (12)

Grenoble University Hospital; 🇫🇷 Grenoble, France

Tours University Hospital; 🇫🇷 Tours, France

La Roche sur Yon Hospital; 🇫🇷 La Roche sur Yon, France

Hospital of Saint Nazaire; 🇫🇷 Saint-Nazaire, France

Angers University Hospital; 🇫🇷 Angers, France

CH de Gonesse; 🇫🇷 Gonesse, France

Hospital of Chateaubriant; 🇫🇷 Chateaubriant, France

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

Nantes University Hospital; 🇫🇷 Nantes, France

Le Mans University Hospital; 🇫🇷 Le Mans, France

Quimper Hospital; 🇫🇷 Quimper, France

Rennes University Hospital; 🇫🇷 Rennes, France