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Acetaminophen IV vs Hydromorphone IV in the ED

Primary Purpose

Pain, Acute

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Hydromorphone
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Acetaminophen, Hydromorphone, Emergency Department, Narcotics, Analgesics, Opioid, Analgesics, Non-Narcotic

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 21 through 64 years of age: This is a study of adult ED patients.
  • Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
  • ED attending physician's judgment that the patient's pain warrants IV opioids.
  • ED attending physician's judgment that the patient has capacity to provide informed consent.
  • Patients must be able to understand English or Spanish.

Exclusion Criteria:

  • Use of opioids or tramadol within past 24 hours.
  • Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours.
  • Prior adverse reaction to opioids or acetaminophen.
  • Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
  • Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease
  • Pregnant or breastfeeding
  • Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
  • SBP <100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  • HR < 60/min: Opioids can cause bradycardia.
  • Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
  • Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
  • Patients using transdermal pain patches: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
  • Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort.
  • Patients who have been previously enrolled in this same study: Patients may only be enrolled once.

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Acetaminophen

Hydromorphone

Arm Description

Outcomes

Primary Outcome Measures

NRS Change at 60 minutes
Between group difference in change in NRS pain scores from baseline

Secondary Outcome Measures

Forego Additional Pain Medication
Difference in proportion of patients who choose to forego additional pain medication
Receive Rescue Medication
Difference in proportion of patients who receive additional pain medication before primary outcome
Experience Medication Side Effects
Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories.

Full Information

First Posted
April 5, 2017
Last Updated
November 14, 2017
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03107481
Brief Title
Acetaminophen IV vs Hydromorphone IV in the ED
Official Title
Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 4, 2017 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
The purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.
Detailed Description
This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency Department. Enrolled subjects presenting to the ED with acute pain will be randomized to receive either acetaminophen 1g IV or hydromorphone 1mg IV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
Acetaminophen, Hydromorphone, Emergency Department, Narcotics, Analgesics, Opioid, Analgesics, Non-Narcotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Title
Hydromorphone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen 1g IV
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Hydromorphone 1mg IV
Primary Outcome Measure Information:
Title
NRS Change at 60 minutes
Description
Between group difference in change in NRS pain scores from baseline
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Forego Additional Pain Medication
Description
Difference in proportion of patients who choose to forego additional pain medication
Time Frame
60 minutes
Title
Receive Rescue Medication
Description
Difference in proportion of patients who receive additional pain medication before primary outcome
Time Frame
Before 60 minutes
Title
Experience Medication Side Effects
Description
Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories.
Time Frame
120 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21 through 64 years of age: This is a study of adult ED patients. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature. ED attending physician's judgment that the patient's pain warrants IV opioids. ED attending physician's judgment that the patient has capacity to provide informed consent. Patients must be able to understand English or Spanish. Exclusion Criteria: Use of opioids or tramadol within past 24 hours. Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours. Prior adverse reaction to opioids or acetaminophen. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease Pregnant or breastfeeding Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. SBP <100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. HR < 60/min: Opioids can cause bradycardia. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. Patients using transdermal pain patches: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments. Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort. Patients who have been previously enrolled in this same study: Patients may only be enrolled once.
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
No
Citations:
PubMed Identifier
30119941
Citation
Barnaby DP, Chertoff AE, Restivo AJ, Campbell CM, Pearlman S, White D, Bijur PE, Gallagher EJ. Randomized Controlled Trial of Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain in the Emergency Department. Ann Emerg Med. 2019 Feb;73(2):133-140. doi: 10.1016/j.annemergmed.2018.06.019. Epub 2018 Aug 14.
Results Reference
derived

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Acetaminophen IV vs Hydromorphone IV in the ED

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