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

Pain Management Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04148495
• Other study ID #: RC19_0116
• Status: Recruiting
• Phase: Phase 4
• Start date: December 3, 2019
• Est. completion date: June 3, 2024

Study information

• Verified date: April 2022
• Source: Nantes University Hospital
• Contact: Céline LONGO, Doctor
• Phone: +33 2 53 48 20 44
• Email: celine.longo[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 572
• Est. completion date: June 3, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Pain Management

Intervention

Drug:
• placebo of acetaminophen IV
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 IV
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

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Bordeaux University Hospital	Bordeaux
France	Châteaubriant Hôspital	Châteaubriant
France	Grenoble University Hospital	Grenoble
France	La Roche-sur-Yon Hospital	La Roche-sur-Yon
France	Nancy University Hospital	Nancy
France	Nantes University Hospital	Nantes
France	La Pitié-Salpêtrière University Hospital	Paris
France	Lariboisière University Hospital - APHP	Paris
France	ROUEN University hospital	Rouen
France	CH Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 minutes
Secondary	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).	60 minutes
Secondary	Estimated cumulative dose of morphine in both arms at a dose -by-weight (mg/kg) dose during the first 30 minutes		30 minutes
Secondary	Frequency and intensity of adverse reactions: nausea, vomiting, respiratory failure, hypotension		through study completion, an average of 60 minutes