Pain ManagementPhase 4ADAMOPANCT04148495
Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department
A Phase 4 study testing acetaminophen IV in people with Pain Management, run by Nantes University Hospital at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- acetaminophen IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 11 sitesFrance
- Study dates
- 3 Dec 2019to 17 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Angers University Hospital
Angers, 49100
Bordeaux University Hospital
Bordeaux, 33000
Châteaubriant Hôspital
Châteaubriant, 44146
Grenoble University Hospital
Grenoble, 38700
La Roche-sur-Yon Hospital
La Roche-sur-Yon, 85925
Nancy University Hospital
Nancy, 54035
Nantes University Hospital
Nantes, 44093
Lariboisière University Hospital - APHP
Paris, 75010
La Pitié-Salpêtrière University Hospital
Paris, 75013
ROUEN University hospital
Rouen, 76000
CH Saint Nazaire
Saint-Nazaire, 44
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- placebo of acetaminophen IV, acetaminophen IV
- Keywords
- Morphine, acetaminophen, Acute pain, Analgesics
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo of acetaminophen IVDrug
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%
acetaminophen IVDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Morphine IV and the placebo of acetaminophen IV. Receives: Drug: placebo of acetaminophen IV |
| Control group | Active comparator | Morphine IV and acetaminophen IV Receives: Drug: acetaminophen IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 60 minutes
Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes
Measured: 30 minutes
Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension
Measured: through study completion, an average of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start3 Dec 2019
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline LONGO, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148495
- Sponsor's protocol ID
- RC19_0116
- Acronym
- ADAMOPA
- Status last verified
- Jan 2025
- First submitted
- 28 Oct 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cattin G, Viglino D, Segard J, Volteau C, Chauvin A, Galinski M, Maigre O, Delamare-Fauvel A, Le Pottier M, Debierre V, Chouihed T, Longo C, Jenvrin J, Freund Y, Montassier E. Morphine Plus Placebo vs Morphine Plus Acetaminophen for Acute Pain in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560250. doi: 10.1001/jamanetworkopen.2025.60250.
PubMed 41733913Cattin 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.
PubMed 36522767
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04148495
- Acronym / sponsor ID
- ADAMOPA / RC19_0116
- Conditions
- Pain Management
- Keywords
- Morphine, acetaminophen, Acute pain, Analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: placebo of acetaminophen IVMorphine IV and the placebo of acetaminophen IV. |
| Control group | Active comparator | Drug: acetaminophen IVMorphine IV and acetaminophen IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo of acetaminophen IVMophine 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% | Drug | Treatment group |
| acetaminophen IVMophine 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 | Drug | Control group |
Primary outcome
Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 30 minutes.
Time frame: 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).
3 secondary outcomes
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.
Time frame: 60 minutes
Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes
Time frame: 30 minutes
Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension
Time frame: through study completion, an average of 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 41733913Cattin G, Viglino D, Segard J, Volteau C, Chauvin A, Galinski M, Maigre O, Delamare-Fauvel A, Le Pottier M, Debierre V, Chouihed T, Longo C, Jenvrin J, Freund Y, Montassier E. Morphine Plus Placebo vs Morphine Plus Acetaminophen for Acute Pain in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560250. doi: 10.1001/jamanetworkopen.2025.60250.
- Derived from this study: PubMed 36522767Cattin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline LONGO, Doctor principal investigator
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen IV in people with Pain Management, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 30 minutes. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.