search
Back to results

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

Primary Purpose

Pain Management

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
placebo of acetaminophen IV
acetaminophen IV
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management focused on measuring Morphine, acetaminophen, Acute pain, Analgesics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Angers University HospitalRecruiting
  • Bordeaux University HospitalRecruiting
  • Châteaubriant HôspitalRecruiting
  • Grenoble University HospitalRecruiting
  • La Roche-sur-Yon HospitalRecruiting
  • Nancy University Hospital
  • Nantes University HospitalRecruiting
  • Lariboisière University Hospital - APHPRecruiting
  • La Pitié-Salpêtrière University HospitalRecruiting
  • ROUEN University hospital
  • CH Saint NazaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

Morphine IV and the placebo of acetaminophen IV.

Morphine IV and acetaminophen IV

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes
Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension

Full Information

First Posted
October 28, 2019
Last Updated
March 7, 2023
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04148495
Brief Title
Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department
Acronym
ADAMOPA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
June 3, 2024 (Anticipated)
Study Completion Date
June 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management
Keywords
Morphine, acetaminophen, Acute pain, Analgesics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
572 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Morphine IV and the placebo of acetaminophen IV.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Morphine IV and acetaminophen IV
Intervention Type
Drug
Intervention Name(s)
placebo of acetaminophen IV
Intervention 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. Placebo of acetaminophen IV: Sodium chloride 0.9%
Intervention Type
Drug
Intervention Name(s)
acetaminophen IV
Intervention 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. Acetaminophen IV: 1 g
Primary Outcome Measure Information:
Title
Comparison of numeric rating scale pain scores between those who received morphine alone and who received combination of acetaminophen and morphine at 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).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
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.
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).
Time Frame
60 minutes
Title
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
Title
Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension
Time Frame
through study completion, an average of 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline LONGO, Doctor
Phone
+33 2 53 48 20 44
Email
celine.longo@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel MONTASSIER, Pr
Phone
+33 2 53 48 20 38
Email
Emmanuel.MONTASSIER@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline LONGO, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion LE POTTIER, Doctor
Phone
(+33) 2 41 35 36 37
Email
marion.lePottier@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Doctor
First Name & Middle Initial & Last Name & Degree
Marion LE POTTIER, Doctor
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel GALINSKI
Phone
(+33) 5 56 79 48 26
Email
michel.galinski@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Michel GALINSKI
Facility Name
Châteaubriant Hôspital
City
Châteaubriant
ZIP/Postal Code
44146
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas HOURDIN, Doctor
Phone
(+33) 2 40 55 88 88
Email
nicolas.hourdin@ch-cnp.fr
First Name & Middle Initial & Last Name & Degree
Nicolas HOURDIN, Doctor
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien VIGLINO
Phone
(+33) 4 76 76 67 84
Email
dviglino@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Damien VIGLINO
Facility Name
La Roche-sur-Yon Hospital
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie DEBIERRE, Doctor
Phone
(+33) 2 51 44 62 05
Email
valerie.debierre@chd-vendee.fr
First Name & Middle Initial & Last Name & Degree
Doctor
First Name & Middle Initial & Last Name & Degree
Valérie DEBIERRE
Facility Name
Nancy University Hospital
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tahar CHOUIEB, Doctor
Phone
(+33) 3 83 85 98 46
Email
t.chouihed@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Tahar CHOUIEB, Doctor
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline LONGO, Dr
Phone
+33 2 53 48 20 44
Email
celine.longo@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel MONTASSIER, Pr
Phone
+33 2 53 48 20 38
Email
Emmanuel.MONTASSIER@chu-nantes.fr
Facility Name
Lariboisière University Hospital - APHP
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Chauvin
Phone
(0)6 79 10 73 51
Ext
+33
Email
anthony.chauvin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Anthony Chauvin
Facility Name
La Pitié-Salpêtrière University Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonathan FREUND, Doctor
Phone
(+33) 1 42 16 00 00
Email
Yonathanfreund@gmail.com
First Name & Middle Initial & Last Name & Degree
Yonathan FREUND, Doctor
Facility Name
ROUEN University hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alix Delamare
Phone
+332328817
Email
alix.delamare@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Alix Delamare
Facility Name
CH Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien SEGARD
Phone
272278000
Ext
+33
Email
j.segard@ch-saintnazaire.fr
First Name & Middle Initial & Last Name & Degree
Julien SEGARD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs