Phase 2
Completed N=162
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Source: ClinicalTrials.gov NCT03521102 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Clinical Improvement in NRS Pain Score — 62; 63 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Improvement in NRS Pain Score |
62; 63 | — |
| SECONDARY Need for Rescue Medication |
37; 31 | — |
| SECONDARY Improvement in NPS Pain Score by >=50% |
30; 43 | — |
Eligibility Criteria
Inclusion Criteria
- Age equal to 65 or greater
- Pain onset within 7 days with severe pain
- Has capacity to provide informed consent
- Understanding English or Spanish
Exclusion Criteria
- Use of tramadol or opioids within 7 days
- Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
- Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
- Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
- Alcohol intoxication
- Systolic blood pressure: 10 days in the prior month
- Prior enrollment in the same study
Data sourced from ClinicalTrials.gov (NCT03521102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.