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Acetaminophen IV vs Hydromorphone IV in the ED

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03107481
First Posted: April 11, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Douglas P. Barnaby, MD, MS, Montefiore Medical Center
  Purpose
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.

Condition Intervention Phase
Pain, Acute Drug: Acetaminophen Drug: Hydromorphone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Douglas P. Barnaby, MD, MS, Montefiore Medical Center:

Primary Outcome Measures:
  • NRS Change at 60 minutes [ Time Frame: 60 minutes ]
    Between group difference in change in NRS pain scores from baseline


Secondary Outcome Measures:
  • Forego Additional Pain Medication [ Time Frame: 60 minutes ]
    Difference in proportion of patients who choose to forego additional pain medication

  • Receive Rescue Medication [ Time Frame: Before 60 minutes ]
    Difference in proportion of patients who receive additional pain medication before primary outcome

  • Experience Medication Side Effects [ Time Frame: 120 Minutes ]
    Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories.


Enrollment: 220
Actual Study Start Date: June 4, 2017
Study Completion Date: November 14, 2017
Primary Completion Date: November 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Drug: Acetaminophen
Acetaminophen 1g IV
Active Comparator: Hydromorphone Drug: Hydromorphone
Hydromorphone 1mg IV

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107481


Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Responsible Party: Douglas P. Barnaby, MD, MS, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03107481     History of Changes
Other Study ID Numbers: 2016-7296
First Submitted: April 5, 2017
First Posted: April 11, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Douglas P. Barnaby, MD, MS, Montefiore Medical Center:
Acetaminophen
Hydromorphone
Emergency Department
Narcotics
Analgesics, Opioid
Analgesics, Non-Narcotic

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Analgesics
Hydromorphone
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants