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Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00305110
First received: March 17, 2006
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain


Condition Intervention Phase
Acute Pain
 Drug: Hydromorphone 2mg intravenous
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • The primary outcome of this study is the incidence of a serious adverse event by 120 minutes post infusion, which is defined as the use of naloxone as a reversal agent.

Secondary Outcome Measures:
  • RR < 12 breaths per minute will be considered a less serious adverse event
  • The RAs will note the presence of oxygen desaturation, defined as a pulse oximeter reading less than 90% or a decrease of 5% or more from baseline
  • Systolic BP less than 90mg Hg will be counted as a less serious adverse event

Estimated Enrollment: 300
Study Start Date: January 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age greater than 21 years
  2. Age less than 65 years of age
  3. Pain with onset within 7 days
  4. ED attending physician's judgment that patient's pain warrants use of morphine
  5. Normal mental status

Exclusion Criteria:

  1. Prior use of methadone
  2. Use of other opioids or tramadol within past seven days
  3. Prior adverse reaction to hydromorphone.
  4. Chronic pain syndrome
  5. Alcohol intoxication
  6. SBP <90 mm Hg
  7. Use of MAO inhibitors in past 30 days
  8. C02 measurement greater than 46
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305110

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Andrew K Chang, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Andrew Chang, MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00305110     History of Changes
Other Study ID Numbers: MMC 0511307
Study First Received: March 17, 2006
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Pain
Acute
Emergency Department
Severe
 Hydromorphone
Dilaudid
Adult

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013