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Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01311895
First received: March 4, 2011
Last updated: September 15, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.


Condition Intervention Phase
Acute Pain
 Drug: H2O
Drug: 1+1
 Phase 3

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 Two Protocols Using IV Hydromorphone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Decline additional pain medication [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.


Secondary Outcome Measures:
  • Number of participants with hypotension (SBP < 90 mmHg) [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    The incidence of hypotension from start of study until 120 minutes.

  • Number of participants with bradycardia (HR < 50/min) [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    Number of participants with bradycardia (HR < 50/min) within 120 minutes.

  • Number of patients with nausea and vomiting [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    Number of patients with nausea and vomiting within 120 minutes

  • Number of participants with pruritus [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    Number of participants with pruritus within 120 minutes

  • Number of participants needing naloxone as a reversal agent [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    Number of participants needing naloxone as a reversal agent within 120 minutes


Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H2O
2 mg IV hydromorphone
 Drug: H2O
2 mg IV hydromorphone
Experimental: 1+1
1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"
 Drug: 1+1
1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's ED.
  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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311895

Contacts
Contact: Andrew Chang, MD, MS 718-920-6626 achang3@yahoo.com

Locations
United States, New York
Montefiore Medical Center Moses Division Emergency Department Recruiting
Bronx, New York, United States, 10467
Contact: Andrew Chang, MD, MS     718-920-6626     achang3@yahoo.com    
Principal Investigator: Andrew K Chang, MD, MS            
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01311895     History of Changes
Other Study ID Numbers: MMC 10-07-201
Study First Received: March 4, 2011
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
acute
pain
emergency department
hydromorphone

Additional relevant MeSH terms:
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