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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148495
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Management Drug: placebo of acetaminophen IV Drug: acetaminophen IV Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : June 3, 2022

Resource links provided by the National Library of Medicine


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 followed by bolus of 0.05 mg/kg every 10 minutes 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 followed by bolus of 0.05 mg/kg every 10 minutes as reported by the recommandation of experts of the french society of urgency care.

Acetaminophen IV: 1 g





Primary Outcome Measures :
  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. [ 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).


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
  3. Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension [ Time Frame: through study completion, an average of 60 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (systolic blood pressure > 90 or < 180 mmHg, heart rate > 50 or < 150/min, and respiratory rate > 10 or < 30/min).
  • 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 for the current acute pain episode.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148495


Contacts
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Contact: Guillaume CATTIN, Doctor +33 2 40 08 73 78 guillaume.cattin@chu-nantes.fr
Contact: Emmanuel MONTASSIER, Doctor +33 2 53 48 20 38 Emmanuel.MONTASSIER@chu-nantes.fr

Locations
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France
Angers University Hospital Not yet recruiting
Angers, France, 49100
Contact: Marion LE POTTIER, Doctor    (+33) 2 41 35 36 37    marion.lePottier@chu-angers.fr   
Contact: Doctor         
Principal Investigator: Marion LE POTTIER, Doctor         
Bordeaux University Hospital Not yet recruiting
Bordeaux, France, 33000
Contact: Michel GALINSKI    (+33) 5 56 79 48 26    michel.galinski@chu-bordeaux.fr   
Principal Investigator: Michel GALINSKI         
Châteaubriant Hôspital Not yet recruiting
Châteaubriant, France, 44146
Contact: Nicolas HOURDIN, Doctor    (+33) 2 40 55 88 88    nicolas.hourdin@ch-cnp.fr   
Principal Investigator: Nicolas HOURDIN, Doctor         
Grenoble University Hospital Not yet recruiting
Grenoble, France, 38700
Contact: Maxime MAIGNAN    (+33) 4 76 76 67 84    mmaignan@chu-grenoble.fr   
Principal Investigator: Maxime MAIGNAN         
La Roche-sur-Yon Hospital Not yet recruiting
La Roche-sur-Yon, France, 85925
Contact: Valérie DEBIERRE, Doctor    (+33) 2 51 44 62 05    valerie.debierre@chd-vendee.fr   
Contact: Doctor         
Principal Investigator: Valérie DEBIERRE         
Nancy University Hospital Not yet recruiting
Nancy, France, 54035
Contact: Tahar CHOUIEB, Doctor    (+33) 3 83 85 98 46    t.chouihed@chru-nancy.fr   
Principal Investigator: Tahar CHOUIEB, Doctor         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Guillaume CATTIN, Dr    +33 2 40 08 73 78    guillaume.cattin@chu-nantes.fr   
Contact: Emmanuel MONTASSIER, Dr    +33 2 53 48 20 38    Emmanuel.MONTASSIER@chu-nantes.fr   
La Pitié-Salpêtrière University Hospital Not yet recruiting
Paris, France, 75013
Contact: Yonathan FREUND, Doctor    (+33) 1 42 16 00 00    Yonathanfreund@gmail.com   
Principal Investigator: Yonathan FREUND, Doctor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Guillaume CATTIN, Doctor Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04148495    
Other Study ID Numbers: RC19_0116
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Morphine
acetaminophen
Acute pain
Analgesics
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics