Comparison of efficacy and safety of single dose transdermal ketoprofen and diclofenac patches in post-operative pain management in patients undergoing lower limb orthopedic procedures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- postoperative pain was taken in a visual analogue scale
研究概览
简要总结
Preoperatively demographic data like age, gender weight, BMI were noted. On the day of surgery patients were shifted to the operating room, standard monitors were applied, two wide bore intravenous cannula placed and spinal anesthesia were given. Two hours after administering the spinal anaesthesia, the corresponding transdermal patch was applied. The patch was applied to non- hairy areas of the body preferably in the upper chest or deltoid region. In the immediate postoperative period no other analgesics were given. To assess the postoperative pain visual analogue scale (VAS) were used. VAS score was recorded at 4,6,8,12, and 24 hours postoperatively. Sleep interference score was also recorded on a 10-point scale that described how the pain had interfered with patient’s sleep during the first 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •who were all undergoing lower limb surgeries (ORIF).
排除标准
- •pregnant or lactating mothers, patients on chronic pain treatment, patients with known allergy to the study drug, with any bleeding disorders, with history of impaired cognitive functions and history of alcohol and substance abuse.
结局指标
主要结局
postoperative pain was taken in a visual analogue scale
时间窗: visual analogue scale (VAS) were used. VAS score was recorded at 4,6,8,12 and 24 hours postoperatively
次要结局
- Sleep interference score was also recorded on a 10-point scale(how the pain had interfered with patient’s sleep during the first 24 hours)
研究者
Pavithira Sekar
Sri Lalithambigai medical college