Comparing Intravenous Hydromorphone to Usual Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Montefiore Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01429298
First received: September 2, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

In this randomized controlled trial, 2 mg IV hydromorphone will be more efficacious than usual care (usual care is analgesic management according to the judgment of the attending physician caring for that patient) in emergency department (ED) patients aged 21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who choose to forgo additional pain medication in 30 minutes of entry into the study and the change in NRS pain scores from baseline to 30 minutes post baseline.


Condition Intervention Phase
Pain
Drug: 2 mg IV hydromorphone
Drug: Usual care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing IV Hydromorphone to Usual Care

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Difference in successful treatment at 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Difference in proportion of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, "Do you want more pain medication?"


Enrollment: 350
Study Start Date: March 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H2O
2 mg IV hydromorphone
Drug: 2 mg IV hydromorphone
2 mg IV hydromorphone
Other Name: Dilaudid
Active Comparator: Usual care
The attending physician administer whatever IV opioid he/she chooses in whatever dose he/she chooses
Drug: Usual care
Attending administers IV opioid of his choosing

  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 and less than 65 years: This is a study of non-elderly adult patients.
  2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
  3. ED attending physician's judgment that patient's pain warrants IV opioids: The factors that influence the decision to use parenteral opioids are complex. An approach that is commonly taken to address the issue of patient selection in drug trials is to use a specific condition (e.g., renal colic) that would generally be thought to be appropriately treated with an opioid analgesic, thereby eliminating individual judgment about eligibility for the study. However in order to maximize the external validity of the role of opioids in the ED setting, the investigators decided to enroll patients with a variety of diagnoses, all with a complaint of acute pain. Opioids are not an appropriate treatment for all patients who present with a complaint of pain (e.g., gastroenteritis, migraine). Therefore, unless there is a restriction to patients with a specific diagnosis, either an extensive list of diagnoses and situations in which opioids are indicated must be specified, or clinical judgment needs to be used. The investigators have opted for the latter, since it most closely approximates the circumstances of clinical practice.

Exclusion Criteria:

  1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
  2. Prior adverse reaction to opioids.
  3. 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.
  4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
  5. SBP <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  6. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
  7. 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.
  8. C02 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:

    • All patients who have a history of COPD
    • All patients who report a history of asthma together with greater than a 20 pack-year smoking history
    • All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01429298

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

No publications provided by Montefiore Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Chang, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01429298     History of Changes
Other Study ID Numbers: MMC 09-11-346
Study First Received: September 2, 2011
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Acute
Pain
Emergency Department
Hydromorphone
Protocol

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

ClinicalTrials.gov processed this record on August 18, 2014