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

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ClinicalTrials.gov Identifier: NCT00305110
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:
Montefiore Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Pain Drug: Hydromorphone 2mg intravenous Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. RR < 12 breaths per minute will be considered a less serious adverse event
  2. 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
  3. Systolic BP less than 90mg Hg will be counted as a less serious adverse event


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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Andrew Chang, MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00305110     History of Changes
Obsolete Identifiers: NCT01006850
Other Study ID Numbers: MMC 0511307
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents