Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)
研究概览
简要总结
The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg iv during a painful and unavoidable intervention in critically ill patients.
详细描述
In 2006, in the Intensive Care Unit (ICU) of the St. Antonius Hospital an analgesia improvement program has been implemented. This program consisted of training of ICU nurses and intensivists using a hospital based standardized pain protocol, and systematic pain measurements in rest, rated by the patient himself whenever possible or otherwise by the attending nurse. This program has resulted in a reduction of severe pain levels (NRS≥4) in ICU patients in rest from 41% to 22%. In order to further reduce this percentage, a pain titration protocol is introduced in 2007. As no attention has yet been paid to intervention-related pain levels in these patients, in this prospective study pain control will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around unavoidable painful interventions within a pain titration protocol for pain control in rest.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.
排除标准
- •Pregnancy/ breastfeeding
- •Language barrier
- •Known morphine iv allergy
- •Comatose patients (cooled)
- •Patients who are suspected to be brain-dead
- •Unintubated patients on the verge of intubation due to respiratory insufficiency
研究组 & 干预措施
A
patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU
干预措施: morphine (Drug)
结局指标
主要结局
The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)
时间窗: The first intervention one day after admission
次要结局
- Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)(10 days)
- Pharmacodynamic parameters of morphine iv (EC50 etc)(10 days)
- Covariates for the PK/PD of morphine iv(10 days)
- Safety and other measures of the analgesics (morphine iv and paracetamol) used for intervention related pain as well as pain titration protocol for pain control in rest.(10 days)
- The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)(10 days)
- The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay(10 days)
- The mean NRS per patient in rest during ICU stay(10 days)
- The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)(one day after admission in the ICU)