Pain Management
Conditions
Keywords
Morphine, Ketamine, Acute pain, prehospital
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.
Interventions
DRUGKetamine
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
DRUGMorphine
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
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection. | 30 minutes |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed