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临床试验/NCT00115180
NCT00115180已完成不适用

Racial and Ethnic Disparities in Acute Pain Control

Agency for Healthcare Research and Quality (AHRQ)2 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
285
试验地点
2
主要终点
Receipt of any analgesics

研究概览

简要总结

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.

详细描述

The study was conducted at two urban academic Emergency Departments associated with Montefiore Medical Center. Emergency Medicine residents and full-time Emergency Medicine faculty are present at both sites. One of the sites is a municipal hospital Level 1 Trauma Center managing approximately 50,000 adult patients per year. The other site is the primary academic medical center, managing approximately 80,000 adult patients per year, many of them requiring tertiary care. Both departments serve an urban population that is predominantly African-American and Hispanic.

Study Protocol Data were obtained from a convenience sample of patients from September, 2003 through November, 2006. Patients were eligible if the provider suspected an isolated long-bone fracture and long-bone films were obtained. Because it was not possible to determine which patients would have positive films in advance, all patients with suspected fractures who met other inclusion criteria were initially considered eligible and enrolled. Only those with confirmed fractures were included in the final study sample. Patients were considered to have fractures if the radiology report by an attending radiologist specified an isolated long-bone fracture defined as a fracture of the humerus, radius, ulna, femur, tibia, or fibula (ICD-9 codes: 812, 813, 821, 823, and 824).

Data collection took place from 8:00 am to midnight seven days a week at one institution and 24 hours a day, seven days a week at the other. Data were collected on a standardized data collection instrument by trained fluently bilingual (Spanish and English) Research Associates. The Research Associates attended a three-day course in research ethics, and specific data collection procedures of the study. This was followed by a two-week internship during which new Research Associates were paired with more experienced Research Associates.

Research Associates approached patients whose triage note indicated an extremity injury, extremity pain, if the Research Associate observed a physical indication of extremity injury, or if a provider identified a patient who was potentially eligible for the study. Eligible patients were asked to sign informed consent. Data were collected from patients at the time of the physician's examination of the patient (baseline) and at discharge. At discharge the treating physician was asked to rate the patient's pain when he/she first examined the patient. If the physician's shift ended before the patient was discharged he/she was asked to rate the patient's initial pain before leaving the ED.

Measurements 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Receipt of any analgesics

时间窗: During Emergency Room visit

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.

次要结局

  • 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)

研究者

发起方
Agency for Healthcare Research and Quality (AHRQ)
申办方类型
Fed
责任方
Principal Investigator
主要研究者

polly bijur

Professor of Emergency Medicine

Agency for Healthcare Research and Quality (AHRQ)

研究点 (2)

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