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Completed

NCT Number: NCT04148495

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

placebo of acetaminophen IV

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%

Acetaminophen IV

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: ADAMOPA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2019
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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