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

Phase 4

Completed

• Conditions: Pain Management
• Interventions: Drug: placebo of acetaminophen IV; Drug: acetaminophen IV

• Registration Number: NCT04148495
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Study Start: 2019-12-03
• Primary Completion: 2024-12-17
• Study Completion: 2024-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	placebo of acetaminophen IV	Morphine IV and the placebo of acetaminophen IV.
Control group	acetaminophen IV	Morphine IV and acetaminophen IV

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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
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	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).

Trial Locations

Locations (11)

Angers University Hospital; 🇫🇷 Angers, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Châteaubriant Hôspital; 🇫🇷 Châteaubriant, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

Nancy University Hospital; 🇫🇷 Nancy, France

La Pitié-Salpêtrière University Hospital; 🇫🇷 Paris, France

La Roche-sur-Yon Hospital; 🇫🇷 La Roche-sur-Yon, France

CH Saint Nazaire; 🇫🇷 Saint Nazaire, France

Nantes University Hospital; 🇫🇷 Nantes, France

ROUEN University hospital; 🇫🇷 Rouen, France

Lariboisière University Hospital - APHP; 🇫🇷 Paris, France