Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial
Overview
- Phase
- Phase 4
- Intervention
- placebo of acetaminophen IV
- Conditions
- Pain Management
- Sponsor
- Nantes University Hospital
- Enrollment
- 415
- Locations
- 11
- Primary Endpoint
- Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 30 minutes.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In emergency medicine, acute pain is a common reason for consultation. It is recommended that patients in moderate to severe pain should receive a combination of intravenous acetaminophen and morphine. However, the data are sparse to support this strategy. Thus, the purpose of our research is to test non-inferiority of IV morphine alone versus IV acetaminophen and morphine in a multicenter, randomized, controlled double blind trial in ED patients with moderate to severe acute pain.
Detailed Description
This study is designed to assess whether IV morphine alone is non inferior to combination IV acetaminophen and morphine for the management of moderate to severe pain in the ED. Numeric rating scale pain score will be compared between those who receive morphine alone and who will receive acetaminophen and morphine at 15, 30, 45 and 60 min post first injection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 Years and older
- •Moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to
- •Conscious patient
- •Clinical stability at the physician's discretion
- •Patient able to talk and give a verbal assessment of his/her pain with the numerical verbal scale
- •Out of guardianship and/or tutorship
- •Affiliated to the social security plan.
Exclusion Criteria
- •Pregnancy and Breast-feeding
- •Patient Unable to give numeric rating scale scores
- •Patient with a weight strictly less than 50kg.
- •acute pulmonary edema, acute respiratory failure
- •Acute coronary syndrome or unbalanced ischemic heart disease in progress.
- •Acute alcoholic intoxication.
- •Patient who received morphine, or acetaminophen, or analgesic, or anti-inflammatory, for the current acute pain episode, within 8 hours prior to arrival at the emergencies
- •No possibility of having venous access
- •History of chronic pain during treatment.
- •Allergy, intolerance or know contraindication to paracetamol or morphine or to an excipient.
Arms & Interventions
Treatment group
Morphine IV and the placebo of acetaminophen IV.
Intervention: placebo of acetaminophen IV
Control group
Morphine IV and acetaminophen IV
Intervention: acetaminophen IV
Outcomes
Primary Outcomes
Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 30 minutes.
Time Frame: 30 minutes
The Numerical Pain Rating Scale measures the perception of pain intensity with an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Secondary Outcomes
- Comparison of numeric rating scale pain scores between those who received morphine alone and who received the combination of acetaminophen and morphine at 10min, 20 min, 45 min and 60min.(60 minutes)
- Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes(30 minutes)
- Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension(through study completion, an average of 60 minutes)