Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 6:41 AM
Study NCT ID:
NCT04148495
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '30 minutes', 'description': '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).'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '60 minutes', 'description': '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).'}, {'measure': 'Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes', 'timeFrame': '30 minutes'}, {'measure': 'Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension', 'timeFrame': 'through study completion, an average of 60 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morphine', 'acetaminophen', 'Acute pain', 'Analgesics'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '36522767', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 Years and older\n* Moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5.\n* Conscious patient\n* Clinical stability at the physician's discretion\n* Patient able to talk and give a verbal assessment of his/her pain with the numerical verbal scale\n* Out of guardianship and/or tutorship\n* Affiliated to the social security plan.\n\nExclusion Criteria:\n\n* Pregnancy and Breast-feeding\n* Patient Unable to give numeric rating scale scores\n* Patient with a weight strictly less than 50kg.\n* acute pulmonary edema, acute respiratory failure\n* Acute coronary syndrome or unbalanced ischemic heart disease in progress.\n* Acute alcoholic intoxication.\n* 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\n* No possibility of having venous access\n* History of chronic pain during treatment.\n* Allergy, intolerance or know contraindication to paracetamol or morphine or to an excipient.\n* Renal or hepatic insufficiency.\n* Association with buprenorphine, nalbuphine and pentazocine.\n* Patient unable or unable to give written consent."}, 'identificationModule': {'nctId': 'NCT04148495', 'acronym': 'ADAMOPA', 'briefTitle': 'Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'RC19_0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Morphine IV and the placebo of acetaminophen IV.', 'interventionNames': ['Drug: placebo of acetaminophen IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Morphine IV and acetaminophen IV', 'interventionNames': ['Drug: acetaminophen IV']}], 'interventions': [{'name': 'placebo of acetaminophen IV', 'type': 'DRUG', 'description': '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.\n\nPlacebo of acetaminophen IV: Sodium chloride 0.9%', 'armGroupLabels': ['Treatment group']}, {'name': 'acetaminophen IV', 'type': 'DRUG', 'description': '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.\n\nAcetaminophen IV: 1 g', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '44146', 'city': 'Châteaubriant', 'country': 'France', 'facility': 'Châteaubriant Hôspital', 'geoPoint': {'lat': 47.71675, 'lon': -1.37643}}, {'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche-sur-Yon Hospital', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'Nancy University Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Lariboisière University Hospital - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'La Pitié-Salpêtrière University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'ROUEN University hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'CH Saint Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}], 'overallOfficials': [{'name': 'Céline LONGO, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}