Racial and Ethnic Disparities in Acute Pain Control

NCT00115180 | Completed

• 1 other identifier: R01HS013924
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fracture; Pain

Keywords

analgesia; adult; opioid; Long Bone Fractures

Outcome Measures

Primary Outcomes (1)

• Receipt of any analgesics

  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.

  During Emergency Room visit

Secondary Outcomes (4)

• Receipt of opioid analgesics

  During Emergency Room visit

• Time to first treatment with analgesic

  During Emergency Room visit

• Receipt of parenteral analgesics

  During Emergency Room visit

• Initial dose of opioid analgesic mg/kg

  During Emergency Room visit

Other Outcomes (2)

• Pain at discharge from Emergency Department

  During Emergency Room visit

• Difference in pain from baseline assessment to discharge from Emergency Department

  During Emergency Room visit

Study Arms (3)

Hispanic

Hispanic patients with long bone fractures no intervention

Other: No intervention

White

White patients with long bone fractures no intervention

Other: No intervention

African-American

African-American patients with long bone fracture no intervention

Other: No intervention

Interventions

No intervention OTHER

No intervention

African-American; Hispanic; White

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Emergency Department patients with radiologically confirmed long bone fractures

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): lead

Study Sites (2)

Jacobi Medical Center Emergency Department

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center Emergency Department

The Bronx, New York, 10467, United States

Location

Related Publications (3)

• Bijur P, Berard A, Esses D, Calderon Y, Gallagher EJ. Race, ethnicity, and management of pain from long-bone fractures: a prospective study of two academic urban emergency departments. Acad Emerg Med. 2008 Jul;15(7):589-97. doi: 10.1111/j.1553-2712.2008.00149.x.

  PMID: 18691208 BACKGROUND

• Bijur P, Berard A, Nestor J, Calderon Y, Davitt M, Gallagher EJ. No racial or ethnic disparity in treatment of long-bone fractures. Am J Emerg Med. 2008 Mar;26(3):270-4. doi: 10.1016/j.ajem.2007.05.010.

  PMID: 18358935 BACKGROUND

• Bijur PE, Berard A, Esses D, Nestor J, Schechter C, Gallagher EJ. Lack of influence of patient self-report of pain intensity on administration of opioids for suspected long-bone fractures. J Pain. 2006 Jun;7(6):438-44. doi: 10.1016/j.jpain.2006.01.451.

  PMID: 16750800 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Pain; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• E. John Gallagher, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: June 21, 2005
• First Posted: June 22, 2005
• Study Start: September 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 7, 2016

Record last verified: 2005-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)