Phase 2 N=162 Randomized Triple-blind Treatment

Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

Acute Pain

Bottom Line

View on ClinicalTrials.gov: NCT03521102 ↗

Enrolled (actual)

162

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Clinical Improvement in NRS Pain Score — 62; 63 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acetaminophen 1000mg IV (Drug); Hydromorphone 0.5 mg IV (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Oct 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.