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临床试验/NCT00738036
NCT00738036已完成不适用

Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
1
主要终点
Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up

研究概览

简要总结

To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy.

The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 or more.
  • Patients under opioid maintenance therapy (buprenorphine or methadone)
  • Patients treated by the same drug (buprenorphine or methadone) since at least 3 months

排除标准

  • Refusal of the patient to take part in the study
  • Absence of possible follow-up

结局指标

主要结局

Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up

时间窗: 1, 3, 6 and 12 months

次要结局

  • pain, anxiety, drugs, alcohol and other substances abuse and dependence, drug prescription (included for pain treatment and opioid maintenance)(1, 3, 6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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