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NCT03553498 · ClinicalTrials.gov registry record · Phase 3
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
A Phase 3 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 162
- Enrollment target
NCT03553498: Completed Phase 3 study, sponsored by Albert Einstein College of Medicine.
NCT03553498 is a Phase 3 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 162 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03553498, a Phase 3 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 162 participants
- Enrollment target
Study 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).
Primary Outcome
The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment
Interventions
- DRUG IV acetaminophen
- DRUG hydromorphone
- DRUG IV placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 3 |
What the finished NCT03553498 record still lists
NCT03553498 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 3 interventions - of which IV acetaminophen is the first listed.
NCT03553498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03553498 about?
NCT03553498 is a clinical study titled "IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients". 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).
What is the current status of trial NCT03553498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 162 participants. The study started on 2018-11-27. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT03553498?
The interventions under investigation include: IV acetaminophen (DRUG), hydromorphone (DRUG), IV placebo (DRUG).
Who is sponsoring clinical trial NCT03553498?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03553498's enrollment target sits among peer trials
162 1474th of 2000 higher than 523 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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