Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 885
- 试验地点
- 29
- 主要终点
- Opiate consumption in the post-operative care service
研究概览
简要总结
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.
Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Patient eligible for any surgery requiring postoperative opioid administration;
- •Patient with a social security plan;
- •French-speaking patient
- •Free, informed and oral consent by the patient.
排除标准
- •Woman claiming to be pregnant or breast feeding;
- •Emergency surgery;
- •Patients using preoperative opioids ;
- •Opioid addiction;
- •Patients unable to understand the assessment scales;
- •Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
研究组 & 干预措施
Comfort Group
Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
干预措施: Informed consent (Other)
Comfort Group
Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
干预措施: Surgery (Procedure)
Comfort Group
Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
干预措施: Comfort scale (Behavioral)
Comfort Group
Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
干预措施: Questionnaires (Other)
Pain Group
Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
干预措施: Informed consent (Other)
Pain Group
Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
干预措施: Surgery (Procedure)
Pain Group
Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
干预措施: Pain (Behavioral)
Pain Group
Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
干预措施: Questionnaires (Other)
结局指标
主要结局
Opiate consumption in the post-operative care service
时间窗: 1 day
Opiate consumption in milligrams in the post-operative care service in morphine equivalent.
次要结局
- Opioid consumption in the post-operative care service according to Ambulatory or conventional management(1 day)
- Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;(1 day)
- Opioid consumption in the post-operative care service according to the Type of surgery(1 day)
- Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia(1 day)
- Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.(1 day)
- Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)(1 day)
- Determine if the use of a comfort scale can reduce the time to achieve a Kremlin Bicetre score = 0, or a modified Aldrete score ≥ 9 or a Chung score ≥ 9 (for ambulatory) ;(1 day)