drugset / Trial / NCT03553498

IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

NCT03553498 ↗

Phase 3 Completed 162 enrolled Albert Einstein College of Medicine
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this randomized clinical trial is to compare the analgesic efficacy and side effect profile of IV acetaminophen as an analgesic adjunctive medication to IV hydromorphone for the treatment of acute pain experienced by patients in the Emergency Department (ED).

Timeline

Start
2018-11-27
Primary completion
2019-05-15
Completion
2019-05-15

Outcome

Missed primary endpoint

registry analysis (superiority test); IV Hydromorphone and IV Acetaminophen vs IV Hydromorphone and Placebo; p = 0.08; t-test, 2 sided NCT03553498 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Intravenous
Background Hydromorphone Other / unclassified 1 mg Intravenous

Indications

No indication recorded.