Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Ketamine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine IV<br> | Drug: Ketamine<br>* 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<br>|
| Active Comparator: Morphine IV<br> | Drug: Morphine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine, Ketamine, Acute pain, prehospital