Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia

Phase 3TerminatedNCT03236805

Nantes University Hospital285 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

285

Conditions

Pain Management

Interventions

KetamineDRUG

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

MorphineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Angers University Hospital

Angers, France

University Hospital of Bordeaux

Bordeaux, France

Hospital of Chateaubriant

Châteaubriant, France

Outcomes

Primary Outcomes

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

Time frame: 30 minutes

Secondary Outcomes

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

Data from ClinicalTrials.gov

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