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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: placebo of acetaminophen IV; Drug: acetaminophen IV

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 Type: Interventional
• Enrollment (Anticipated): 572
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Céline LONGO, Doctor; Phone Number: +33 2 53 48 20 44; Email: celine.longo@chu-nantes.fr
• Study Contact Backup: Name: Emmanuel MONTASSIER, Pr; Phone Number: +33 2 53 48 20 38; Email: Emmanuel.MONTASSIER@chu-nantes.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • Angers University Hospital
    • Contact: Marion LE POTTIER, Doctor; Phone Number: (+33) 2 41 35 36 37; Email: marion.lePottier@chu-angers.fr
    • Principal Investigator: Marion LE POTTIER, Doctor
  • Bordeaux, France, 33000
    • Recruiting
    • Bordeaux university hospital
    • Contact: Michel GALINSKI; Phone Number: (+33) 5 56 79 48 26; Email: michel.galinski@chu-bordeaux.fr
    • Principal Investigator: Michel GALINSKI
  • Châteaubriant, France, 44146
    • Recruiting
    • Châteaubriant Hospital
    • Contact: Nicolas HOURDIN, Doctor; Phone Number: (+33) 2 40 55 88 88; Email: nicolas.hourdin@ch-cnp.fr
    • Principal Investigator: Nicolas HOURDIN, Doctor
  • Grenoble, France, 38700
    • Recruiting
    • Grenoble University Hospital
    • Contact: Damien VIGLINO; Phone Number: (+33) 4 76 76 67 84; Email: dviglino@chu-grenoble.fr
    • Principal Investigator: Damien Viglino
  • La Roche-sur-Yon, France, 85925
    • Recruiting
    • La Roche-sur-Yon Hospital
    • Contact: Valérie DEBIERRE, Doctor; Phone Number: (+33) 2 51 44 62 05; Email: valerie.debierre@chd-vendee.fr
    • Principal Investigator: Valérie DEBIERRE
  • Nancy, France, 54035
    • Not yet recruiting
    • Nancy University Hospital
    • Contact: Tahar CHOUIEB, Doctor; Phone Number: (+33) 3 83 85 98 46; Email: t.chouihed@chru-nancy.fr
    • Principal Investigator: Tahar CHOUIEB, Doctor
  • Nantes, France, 44093
    • Recruiting
    • Nantes university hospital
    • Contact: Emmanuel MONTASSIER, Pr; Phone Number: +33 2 53 48 20 38; Email: Emmanuel.MONTASSIER@chu-nantes.fr
    • Contact: Céline LONGO, Dr; Phone Number: +33 2 53 48 20 44; Email: celine.longo@chu-nantes.fr
  • Paris, France, 75010
    • Recruiting
    • Lariboisière University Hospital - APHP
    • Principal Investigator: Anthony Chauvin
    • Contact: Anthony Chauvin; Phone Number: +33 (0)6 79 10 73 51; Email: anthony.chauvin@aphp.fr
  • Paris, France, 75013
    • Recruiting
    • La Pitie-Salpetriere University Hospital
    • Contact: Yonathan FREUND, Doctor; Phone Number: (+33) 1 42 16 00 00; Email: Yonathanfreund@gmail.com
    • Principal Investigator: Yonathan FREUND, Doctor
  • Saint Nazaire, France, 44
    • Not yet recruiting
    • CH Saint Nazaire
    • Contact: Julien SEGARD; Phone Number: +33 272278000; Email: j.segard@ch-saintnazaire.fr
    • Principal Investigator: Julien SEGARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Morphine IV and the placebo of acetaminophen IV.	Drug: 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%
Active Comparator: Control group; Morphine IV and acetaminophen IV	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 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).	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Céline LONGO, Doctor, Nantes university hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Anticipated): June 3, 2024
• Study Completion (Anticipated): June 3, 2024

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: acetaminophen; Morphine; Acute pain; Analgesics
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: RC19_0116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No