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Racial and Ethnic Disparities in Acute Pain Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
polly bijur, Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00115180
First received: June 21, 2005
Last updated: January 5, 2016
Last verified: November 2005
  Purpose

We aim to compare pain management among three groups of ethnic disparity (ED) patients, Hispanics, non-Hispanic Blacks, non-Hispanic Whites, and assess whether the observed association between pain management and race/ethnicity is independent of potentially important confounding variables (e.g., age, sex, insurance status, education). We also aim to assess whether the effect of race/ethnicity on adequacy of pain management is explained by patients' initial pain intensity or by discordance between patient and physician's: a) race/ethnicity; b) perception of patient's pain. To do this 285 patients with long-bone fractures will be recruited in the EDs of one municipal and one voluntary hospital serving an inner-city, disadvantaged population in the Bronx. Data will be collected on pain using self-reported pain and non-verbal pain expressions at baseline, one hour post-baseline, and discharge. Data on analgesics administered, patient and physician characteristics will also be collected.

We plan to conduct a chart review of long bone fractures in 2000 and 2001 so that we can analyze the association between race/ethnicity and pain management using the same design as published studies. Comparison of the retrospective and prospective studies will strengthen inferences that can be drawn.

We hypothesize that Black and Hispanic patients will be less likely to receive opioid analgesics than white patients.


Condition Intervention
Fracture
Pain
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Racial and Ethnic Disparities in Acute Pain Control

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Receipt of any analgesics [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    The names of all medications, dose, route, and time administered were obtained in real time from the chart and ED staff. Patients were categorized as receiving: 1) no analgesics; 2) NSAIDS or acetaminophen; or 3) opioids. If both NSAIDS or acetaminophen and opioids were administered, patients were categorized as having received opioids. Analgesics given solely for fracture reduction were not used to categorize patients. Opioid analgesics were transformed into morphine equivalents as follows: 1 mg morphine = 3 mg of oxycodone; 0.15 mg of hydromorphone, and 13 mg of codeine. No other opioid analgesics were used with the exception of fentanyl, which was only used for fracture reduction.


Secondary Outcome Measures:
  • Receipt of opioid analgesics [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Morphine, hydromorphone, oxycodone, codeine

  • Time to first treatment with analgesic [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Time from triage to first analgesic in minutes

  • Receipt of parenteral analgesics [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Analgesic administered parenterally

  • Initial dose of opioid analgesic mg/kg [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Initial dose of opioid analgesic converted to morphine equivalent units as follows: : 1 mg morphine = 3 mg of oxycodone; 0.15 mg of hydromorphone, and 13 mg of codeine.


Other Outcome Measures:
  • Pain at discharge from Emergency Department [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Patients were asked to rate their pain intensity on a validated and reproducible 11-point numerical rating scale (NRS) ranging from 0 "no pain", to 10 "worst imaginable pain" at the time of discharge from the Emergency Department

  • Difference in pain from baseline assessment to discharge from Emergency Department [ Time Frame: During Emergency Room visit ] [ Designated as safety issue: No ]
    Numerical Rating Scale (NRS) of pain at discharge subtracted from NRS of pain at baseline.


Enrollment: 285
Study Start Date: September 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hispanic
Hispanic patients with long bone fractures no intervention
Other: No intervention
No intervention
White
White patients with long bone fractures no intervention
Other: No intervention
No intervention
African-American
African-American patients with long bone fracture no intervention
Other: No intervention
No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency Department patients with radiologically confirmed long bone fractures
Criteria

Inclusion Criteria:

  • 18 to 55 years;
  • Acute pain starting no more than 24 hours before presenting to the ED;
  • Have isolated long-bone fracture documented on x-ray;
  • Have a complaint of pain at triage or complaining of pain to the physician;
  • English and Spanish speaking

Exclusion Criteria:

  • Participating in another clinical study at the same site time of entry;
  • Unable to complete the pain intensity scale, or complete the questionnaire because of inability to understand the task and questions;
  • Intoxication with alcohol or other drug;
  • Pregnancy;
  • Methadone use;
  • Use of opioids or tramadol in past seven days;
  • Patients who are allergic to any analgesics;
  • Patients with a chronic pain syndrome (sickle cell anemia, fibromyalgia, migraine, peripheral neuropathies)
  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: NCT00115180

Locations
United States, New York
Jacobi Medical Center Emergency Department
Bronx, New York, United States, 10461
Montefiore Medical Center Emergency Department
Bronx, New York, United States, 10467
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Study Chair: E. John Gallagher, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Publications:
Responsible Party: polly bijur, Professor of Emergency Medicine, Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00115180     History of Changes
Other Study ID Numbers: R01HS013924 
Study First Received: June 21, 2005
Last Updated: January 5, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
analgesia
adult
opioid
Long Bone Fractures

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016