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

Acute Pain Clinical Trial

Official title:

An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521102
• Other study ID #: 2018-8876
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2018
• Est. completion date: March 23, 2022

Study information

• Verified date: February 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 23, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Acetaminophen 1000mg IV
1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
• Hydromorphone 0.5 mg IV
100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement in NRS Pain Score	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.	60 minutes following administration of medication
Secondary	Need for Rescue Medication	Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.	120 minutes following administration of medication
Secondary	Improvement in NPS Pain Score by >=50%	The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.	60 minutes after administration of medication