跳至主要内容
临床试验/NCT01626235
NCT01626235已完成不适用

Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain

Radnor Registry Research, Inc10 个研究点 分布在 1 个国家目标入组 843 人开始时间: 2012年7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
843
试验地点
10
主要终点
Clinical Outcomes of pain control measures

研究概览

简要总结

Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.

详细描述

Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Eligible subjects will meet the following criteria:
  • Eligible diagnoses:
  • musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
  • Age GTE 18 years;
  • Decision to discharge from ED to community already made;
  • Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
  • Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
  • Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.

排除标准

  • Eligible subjects will meet none of the following criteria:
  • Patient admitted or placed on observation status from ED;
  • Patient unwilling or unable to comply with telephonic follow-up;
  • Fracture that requires surgical repair (even if at a later date);
  • Patient has diagnosis of any chronic pain syndrome;
  • Patient already routinely takes NSAID or opioid agent;
  • Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
  • Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).

结局指标

主要结局

Clinical Outcomes of pain control measures

时间窗: 5 days

1. Change in pain score over follow-up interval; 2. Healthcare resource utilization during follow-up interval; 3. Patient satisfaction with therapy; 4. Return to work in employed cohort.

次要结局

  • Satisfaction and Economic Outcomes(5 days)

研究者

发起方
Radnor Registry Research, Inc
申办方类型
Industry
责任方
Sponsor

研究点 (10)

Loading locations...

相似试验