Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Efficacy treatment
研究概览
简要总结
The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.
Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.
Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties
The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 75 years
- •Patient schedules for insertion of long-lasting intravenous device
排除标准
- •History of previous insertion of long-lasting intravenous device or central intravenous catheter
- •long term treatment of gabapentin or pregabalin
- •Hypersensitivity to pregabalin or any of the excipients
- •Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
- •Patient at risk of glaucoma e
- •Patient at risk for urinary retention
- •Patient severe respiratory failure
- •Patient at the general condition not too corrupted (ASA IV)
- •Renal failure with creatinin clearance < 30 ml / min
- •Patient not affiliated to Social Security
- •Pregnant or lactating
- •Patients in emergency situations
- •Inpatient without consent
研究组 & 干预措施
Pregabaline
Groups PREGABALINE : 150 mg de LYRICA®
干预措施: Pregabalin (Drug)
Hydroxyzine
Groups HYDROXYZINE : 75 mg d'ATARAX®
干预措施: hydroxyzine (Drug)
Lactose
Groups placebo : 4 g de lactose
干预措施: Lactose (Drug)
结局指标
主要结局
Efficacy treatment
anxiety score VAS: 0 to 100
次要结局
- Efficacy of pregabaldin