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NCT03521102 · ClinicalTrials.gov registry record · Phase 2
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
A Phase 2 study of Acute Pain, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
- 1
- Study location
NCT03521102: Completed Phase 2 study of Acute Pain, sponsored by Montefiore Medical Center.
NCT03521102 is a Phase 2 study of Acute Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 162 participants, below the 265-participant average among 50 other Acute Pain trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03521102, a Phase 2 study of Acute Pain, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.
Primary Outcome
Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of \>=1.3 points on the 0-10 scale.
Conditions Studied
Interventions
- DRUG Acetaminophen 1000mg IV
- DRUG Hydromorphone 0.5 mg IV
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 2 |
What the finished NCT03521102 record still lists
NCT03521102 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 265-participant average among 50 other Acute Pain trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions - of which Acetaminophen 1000mg IV is the first listed.
NCT03521102 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03521102 about?
NCT03521102 is a clinical study titled "Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED". Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for mor...
What is the current status of trial NCT03521102?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2018-08-20. Estimated completion is 2022-03-23.
What conditions does trial NCT03521102 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT03521102?
The interventions under investigation include: Acetaminophen 1000mg IV (DRUG), Hydromorphone 0.5 mg IV (DRUG).
Who is sponsoring clinical trial NCT03521102?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03521102 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03521102's enrollment target sits among peer trials
162 18th of 50 higher than 33 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain 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.
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