Clinical trial

Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial

Name
RC19_0116
Description
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.
Trial arms
Trial start
2019-12-03
Estimated PCD
2024-06-03
Trial end
2024-06-03
Phase
Early phase I
Treatment
placebo of acetaminophen IV
Mophine IV: Initial loading dose of 0.1 mg/kg (ensuring that the maximum dose of 10 mg is not exceeded) followed by bolus of 0.05 mg/kg every 10 minutes (taking care not to exceed the maximum dose of 5 mg) as reported by the recommandation of experts of the french society of urgency care. Placebo of acetaminophen IV: Sodium chloride 0.9%
Arms:
Treatment group
acetaminophen IV
Mophine IV: Initial loading dose of 0.1 mg/kg (ensuring that the maximum dose of 10 mg is not exceeded) followed by bolus of 0.05 mg/kg every 10 minutes ((taking care not to exceed the maximum dose of 5 mg) as reported by the recommandation of experts of the french society of urgency care. Acetaminophen IV: 1 g
Arms:
Control group
Size
572
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.
30 minutes
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 5. * 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. * Renal or hepatic insufficiency. * Association with buprenorphine, nalbuphine and pentazocine. * Patient unable or unable to give written consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 572, 'type': 'ESTIMATED'}}
Updated at
2023-03-08

1 organization

1 product

1 indication

Indication
Pain Management