Does the Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Randomized Controlled Trial in Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
To investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after ambulatory surgery.
The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.
详细描述
Systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. Anxiety might be a confounder in this association. In order to investigate the effect of midazolam on postoperative pain, a clinical trial will be conducted in Portuguese ambulatory surgery units. A convenience sample with consecutive design will include patients admitted for open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery under spinal anesthesia. Patients will be randomized into 3 premedication groups, and this randomization will be stratified for each centre and each type of surgery. Postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months.
The investigators will use multiple regression models to explore the interaction of midazolam dose with preoperative anxiety, gender and chronic benzodiazepine use, as they hypothesize there might be a differential effect of midazolam on postoperative pain amongst these subgroups.
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
- Double (Participant, Outcomes Assessor)
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
- •adult patients submitted to open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery in Portuguese ambulatory surgery units
排除标准
- •psychiatric disorders
- •alcoholism
- •illiteracy or poor understanding of Portuguese language
- •history of chronic pain under opioids
- •recurrent surgery
- •contraindication for midazolam or deep sedation
- •contraindication for spinal anesthesia
研究组 & 干预措施
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Normal saline (Other)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Spinal anesthesia (Procedure)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Surgery (Procedure)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Postoperative analgesia (Drug)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Rescue analgesia (Drug)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Wound infiltration (Drug)
PC1
5mL normal saline intravenous, single-administration, as pre-medication
干预措施: Analgesia at home (Drug)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Midazolam Injectable Solution (Drug)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Normal saline (Other)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Spinal anesthesia (Procedure)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Surgery (Procedure)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Postoperative analgesia (Drug)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Rescue analgesia (Drug)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Wound infiltration (Drug)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Analgesia at home (Drug)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Midazolam Injectable Solution (Drug)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Normal saline (Other)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Spinal anesthesia (Procedure)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Surgery (Procedure)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Postoperative analgesia (Drug)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Rescue analgesia (Drug)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Wound infiltration (Drug)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
干预措施: Analgesia at home (Drug)
结局指标
主要结局
Postoperative pain
时间窗: Day 1 after surgery
Assessed by the Brief Pain Inventory severity score (24h recall time): mean of 4 items assessing pain at the moment of the interview, on average, at its least and at its worst during the last 24h
次要结局
- Postoperative pain(Month 3 after surgery)
- Patient satisfaction(Month 3 after surgery)
- Adverse events(Day 7 after surgery)
- Pain interference in daily life(Month 3 after surgery)
- Analgesic consumption(Day 7 after surgery)
- Global surgery recovery index(Month 3 after surgery)
研究者
Caroline Dahlem
Principal Investigator
Universidade do Porto