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

• Status: Active, not recruiting
• Trial end date: 2022-03-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Acetaminophen; Hydromorphone

Criteria

Inclusion Criteria:

1. Age equal to 65 or greater

2. Pain onset within 7 days with severe pain

3. Has capacity to provide informed consent

4. Understanding English or Spanish

Exclusion Criteria:

1. Use of tramadol or opioids within 7 days

2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours

3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies

4. 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

5. Alcohol intoxication

6. Systolic blood pressure: < 100 mmHg

7. Heart rate: < 60 beats per minute

8. Oxygen saturation: < 95% on room air

9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days

10. Use of transdermal pain patch or oral opioid > 10 days in the prior month

11. Prior enrollment in the same study