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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03521102

Collaborator

(none)

162

Enrollment

Location

Arms

43.1

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: Acetaminophen 1000mg IV Drug: Hydromorphone 0.5 mg IV	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2018

Actual Primary Completion Date :

Oct 30, 2021

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetaminophen 1000mg IV NRS pain scores will be obtained at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.	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
Active Comparator: Hydromorphone 0.5mg IV NRS score will be checked at 5 minutes and every 15 minutes for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.	Drug: 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

Arm

Intervention/Treatment

Experimental: Acetaminophen 1000mg IV

NRS pain scores will be obtained at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.

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

Active Comparator: Hydromorphone 0.5mg IV

NRS score will be checked at 5 minutes and every 15 minutes for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.

Drug: 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

Outcome Measures

Primary Outcome Measures

Verbal pain scale (0-10) [60 minutes]
Improvement in 0-10 verbal pain scale between baseline and at 60 minutes

Secondary Outcome Measures

Need for rescue medication [120 minutes]
Requirement of additional analgesic medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: < 100 mmHg
Heart rate: < 60 beats per minute
Oxygen saturation: < 95% on room air
Use of monoamine oxidase (MAO) inhibitors in the past 30 days
Use of transdermal pain patch or oral opioid > 10 days in the prior month
Prior enrollment in the same study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT03521102

Other Study ID Numbers:

2018-8876

First Posted:

May 11, 2018

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Acute Pain

Acetaminophen

Hydromorphone

Study Results

No Results Posted as of Apr 22, 2022