Clinical trial NCT04148495: Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Management
Keywords: Morphine
acetaminophen
Acute pain
Analgesics
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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
Secondary outcomes:
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
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
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Châteaubriant
country: France
facility: Châteaubriant Hôspital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: La Roche-sur-Yon
country: France
facility: La Roche-sur-Yon Hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Lariboisière University Hospital - APHP
city: Paris
country: France
facility: La Pitié-Salpêtrière University Hospital
city: Rouen
country: France
facility: ROUEN University hospital
city: Saint Nazaire
country: France
facility: CH Saint Nazaire
Study officials:
affiliation: Nantes University Hospital
name: Céline LONGO, Doctor
role: PRINCIPAL_INVESTIGATOR
References: