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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2024-12-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Treatment group

Morphine IV and the placebo of acetaminophen IV.

Group Type EXPERIMENTAL

placebo of acetaminophen IV

Intervention Type DRUG

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%

Control group

Morphine IV and acetaminophen IV

Group Type ACTIVE_COMPARATOR

acetaminophen IV

Intervention Type DRUG

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

Interventions

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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%

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No