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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen 1000mg IV
Hydromorphone 0.5 mg IV
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acetaminophen 1000mg IV

Hydromorphone 0.5mg IV

Arm Description

NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 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.

NRS pain score will be checked at 5 minutes and every 15 minutes thereafter 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Need for Rescue Medication
Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
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.

Full Information

First Posted
April 26, 2018
Last Updated
February 2, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03521102
Brief Title
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Official Title
An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
March 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen 1000mg IV
Arm Type
Experimental
Arm Description
NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 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.
Arm Title
Hydromorphone 0.5mg IV
Arm Type
Active Comparator
Arm Description
NRS pain score will be checked at 5 minutes and every 15 minutes thereafter 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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 1000mg IV
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hydromorphone 0.5 mg IV
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Improvement in NRS Pain Score
Description
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.
Time Frame
60 minutes following administration of medication
Secondary Outcome Measure Information:
Title
Need for Rescue Medication
Description
Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
Time Frame
120 minutes following administration of medication
Title
Improvement in NPS Pain Score by >=50%
Description
The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.
Time Frame
60 minutes after administration of medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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