Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain

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  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01429285
First received: September 2, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

The hydromorphone protocol is more effective than usual care in Emergency Department (ED) patients age 65 years and older in terms of proportion who choose to forgo additional pain medication within 60 minutes post-baseline in the two groups.


Condition Intervention Phase
Pain
Drug: 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: Safety and Efficacy of Intravenous Hydromorphone Using Incremental Doses of 0.5 mg in Elderly ED Patients With Acute Severe Pain

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Proportion with successful treatment [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Proportion of patients who choose to forgo additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?"


Estimated Enrollment: 350
Study Start Date: July 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydromorphone
Hydromorphone protocol
Drug: Hydromorphone
0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
Other Name: Dilaudid
Active Comparator: Usual care
Usual care
Drug: Usual care
Attending administers any IV opioid in any dose he chooses

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 65 years: This is a study of elderly 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 may warrant IV opioids: The factors that influence the decision to use parenteral opioids are complex and extensive. 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) or treatment (e.g., post-hysterectomy) 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 assess the role of opioids with the widest generalizability 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 a comprehensive 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 alternative.
  4. Normal mental status: In order to provide measures of pain experienced the patient needs to have a normal mental status. The investigators will use a 6-item screener (Wilber 2008) as an indicator of sufficiently normal mental status to participate in the study.

Exclusion Criteria:

  1. Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. The investigators feel that the needs of patients on methadone may exceed the dosage ceiling of 1 mg that will be used for this study. Similar to sickle cell patients and chronic cancer patients, patients on methadone usually require significantly higher doses of opioids to control their pain. Thus, the investigators feel that it would be unethical to restrict the dose that this subset of patients can receive.
  2. Use of other opioids or tramadol within past seven days: to avoid introducing bias related to opioid tolerance that may alter the response to the study medication thereby masking the medication's effect.
  3. Prior adverse reaction to opioids.
  4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in alteration in 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, migraine, and peripheral neuropathies.
  5. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain.
  6. SBP <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  7. Oxygen saturation <95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
  8. 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.
  9. C02 measurement greater than 46: In accordance with a similar study (04-12-360), 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429285

Locations
United States, New York
Montefiore Emergency Department Recruiting
Bronx, New York, United States, 10467
Contact: Andrew Chang, MD, MS       achang3@yahoo.com   
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Andrew Chang, Prinicipal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01429285     History of Changes
Other Study ID Numbers: MMC 08-11-387
Study First Received: September 2, 2011
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

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

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 July 29, 2014