CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 415 enrolled
Drug / intervention
placebo of acetaminophen IV +1 moredrug
Likely dose
placebo of acetaminophen IV 0.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04148495
NCT04148495Phase 4Completed

Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial

Nantes University Hospital·interventional·Posted Nov 1, 2019·Updated Jan 13, 2025

In Brief

A Phase 4 clinical trial evaluating placebo of acetaminophen IV and acetaminophen IV for Pain Management. Completed, enrolled 415 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Management
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 1, 2019
Enrollment StartDec 3, 2019
Primary CompletionDec 17, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 6.7 years ago

Interventions

placebo of acetaminophen IVdrug

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 IVdrug

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