65 and older, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Improvement in NRS Pain ScorePrimary· 60 minutes following administration of medication
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.
Group
Value
95% CI
Acetaminophen 1000mg IV
62
Hydromorphone 0.5mg IV
63
Need for Rescue MedicationSecondary· 120 minutes following administration of medication
Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
Group
Value
95% CI
Acetaminophen 1000mg IV
37
Hydromorphone 0.5mg IV
31
Improvement in NPS Pain Score by >=50%Secondary· 60 minutes after administration of medication
The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.
Group
Value
95% CI
Acetaminophen 1000mg IV
30
Hydromorphone 0.5mg IV
43
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
Last refreshed: 2 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03521102.