Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department (ADAMOPA)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 4

Conditions: Pain Management

Treatments: Drug: acetaminophen IV; Drug: placebo of acetaminophen IV

Study type: Interventional

Funder types: Other

Identifiers

NCT04148495

RC19_0116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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415 participants in 2 patient groups

Treatment group

Experimental group

Description:

Morphine IV and the placebo of acetaminophen IV.

Treatment:

Drug: placebo of acetaminophen IV

Control group

Active Comparator group

Description:

Morphine IV and acetaminophen IV

Treatment:

Drug: acetaminophen IV