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临床试验/NCT00999440
NCT00999440Unknown不适用

QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain.

研究概览

简要总结

QTc:

Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been scrutinized for any possible association with TdP. Since then, several studies among Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting diverse results about possible association between methadone dose and QTc prolongation. Most studies however were cross-sectional and generally found insignificant clinical prolongation of QTc. A follow up studies are of importance, and although few studies have started evaluating QTc among MMT patients, none was done among chronic pain patients with no history of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or intolerable side effects during treatment with oral morphine switched to oral methadone showed insignificant modest increase QTc following 9 month.

Perceived Sleep:

Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some studies found possible relation to methadone dose, however, no causal association was found and importantly some also found association with duration of opiate usage before starting methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an important interesting group that may help understand relation between methadone usage and sleep quality. However, sleep must be evaluate before opiate administration and a follow up study is needed

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults (18+ years) patients with chronic pain, who intend to be medicated with any opiates

排除标准

  • patient with no opiate usage through last year

研究组 & 干预措施

Methadone

Experimental

ECG (QT, QTc, Heart rate), Urine sample (opiates, benzodiazepines, THC, cocaine, amphetamines, methadone-metabolite), Questionnaire PSQI - perceived sleep - self report , Pain indices (severity, duration, cause, etc.) , usage of other medication for pain and other significant disease/disorders, history of drug abuse, age, sex, place of birth and ethnic origin, comorbidity. Follow up after 4weeks, 6months and 1 year will be done.Patients who start with any opiate and then switch to methadone, move to methadone follow up

干预措施: Methadone (Drug)

结局指标

主要结局

To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain.

时间窗: 1 year

次要结局

  • To evaluate the perceived sleep in the chronic pain patients(1 year)

研究者

申办方类型
Other Gov

研究点 (1)

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