Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department
ADAMOPA
1 other identifier
interventional
415
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2019
Longer than P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2024
CompletedJanuary 13, 2025
January 1, 2025
5 years
October 28, 2019
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Treatment group
EXPERIMENTALMorphine IV and the placebo of acetaminophen IV.
Control group
ACTIVE COMPARATORMorphine IV and acetaminophen IV
Interventions
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%
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Angers University Hospital
Angers, 49100, France
Bordeaux University Hospital
Bordeaux, 33000, France
Châteaubriant Hôspital
Châteaubriant, 44146, France
Grenoble University Hospital
Grenoble, 38700, France
La Roche-sur-Yon Hospital
La Roche-sur-Yon, 85925, France
Nancy University Hospital
Nancy, 54035, France
Nantes University Hospital
Nantes, 44093, France
Lariboisière University Hospital - APHP
Paris, 75010, France
La Pitié-Salpêtrière University Hospital
Paris, 75013, France
ROUEN University hospital
Rouen, 76000, France
CH Saint Nazaire
Saint-Nazaire, 44, France
Related Publications (1)
Cattin G, Jenvrin J, Hardouin JB, Longo C, Montassier E. Intravenous acetaminophen with morphine versus intravenous morphine alone for acute pain in the emergency room: protocol for a multicenter, randomized, placebo-controlled, double-blinded study (ADAMOPA). Trials. 2022 Dec 15;23(1):1016. doi: 10.1186/s13063-022-06943-0.
PMID: 36522767DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Céline LONGO, Doctor
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 1, 2019
Study Start
December 3, 2019
Primary Completion
December 17, 2024
Study Completion
December 17, 2024
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share