Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia

Pain Management Clinical Trial

— KETAMORPH  

Official title:

Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03236805
• Other study ID #: RC17_0082
• Status: Terminated
• Phase: Phase 3
• Start date: November 23, 2017
• Est. completion date: November 26, 2022

Study information

• Verified date: December 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 285
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

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
• 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

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	University Hospital of Bordeaux	Bordeaux
France	Hospital of Chateaubriant	Chateaubriant
France	CH de Gonesse	Gonesse
France	Grenoble University Hospital	Grenoble
France	La Roche sur Yon Hospital	La Roche sur Yon
France	Le Mans University Hospital	Le Mans
France	Nantes University Hospital	Nantes
France	Quimper Hospital	Quimper
France	Rennes University Hospital	Rennes
France	Hospital of Saint Nazaire	Saint-Nazaire
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.		30 minutes
Secondary	Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.		15 minutes
Secondary	Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.		45 minutes
Secondary	Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.		60 minutes