Text Size

Protocolized vs Discretionary Use of Opioids in Acute Pain

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00825370
First received: January 19, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.


Condition Intervention Phase
Pain
 Drug: Hydromorphone
Drug: IV opioid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocolized vs Discretionary Use of Opioids in Acute Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Difference in proportion who answer "no" to the question, "Do you want more pain medication?" at 60 minutes. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in proportion of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes [ Time Frame: 15 min ] [ Designated as safety issue: No ]
  • Changes in pain intensity from baseline to other pain assessment times (5, 15, 30, 45 and 60 minutes). [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protocolized
1 mg IV 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?"
 Drug: Hydromorphone
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
Other Name: Dilaudid
Active Comparator: Discretionary Care
Patients receive an IV opioid the type and dose of which is determined by the treating physician
 Drug: IV opioid
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Other Name: Discretionary care

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 21 to 64 years.
  2. Pain with onset within 7 days.
  3. ED attending physician's judgment that patient's pain warrants use of intravenous opioids.
  4. Normal mental status.

Exclusion Criteria:

  1. Prior use of methadone.
  2. Use of other opioids, tramadol, or heroin in the past seven days.
  3. Prior adverse reaction to morphine, hydromorphone, or other opioids.
  4. Chronic pain syndrome.
  5. Alcohol intoxication.
  6. Systolic BP < 90 mm Hg.
  7. Use of MAO inhibitors in past 30 days.
  8. Weight less than 100 pounds.
  9. Baseline room air oxygen saturation less than 95%.

  10. C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four 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 4 subsets are as follows:

    1. All patients who have a history of COPD
    2. All patients who have a history of sleep apnea
    3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history
    4. 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: NCT00825370

Locations
United States, New York
Montefiore Medical Center Emergency Department
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, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00825370     History of Changes
Other Study ID Numbers: MMC 0808278
Study First Received: January 19, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Hydromorphone
acute pain
Protocolized
Efficacy
Safety

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 21, 2013