Ibuprofen Use on Post-operative Pain Following Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- VAS scores in the postoperative period
研究概览
简要总结
In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.
详细描述
Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.
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
- Single (Investigator)
盲法说明
Randomization of the participants was performed according to computer-generated random number tables, and allocation to a treatment group was performed using the envelope technique. For each participant taken the operating theater for laparoscopic cholecystectomy, an envelope was randomly selected and the code was recorded. The participants were unaware of which drug was being administered. The researcher who recorded the participants' demographic and follow-up data was also unaware of the type of drug being administered.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA grade I-II patients
- •Aged 18-65 years
排除标准
- •History of allergies or hypersensitivity to the aforementioned agents
- •Renal, hepatic or gastrointestinal disease
- •Significant cognitive impairment
- •Recent use of long-term nonsteroid anti-inflammatory and opioids
- •Oral anticoagulant use or known bleeding disorders
- •Diabetes or any other neuropathic diseases
- •Pregnancy or breastfeeding
研究组 & 干预措施
Acetaminophen group
The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy.
干预措施: Acetaminophen 100 MG/ML (Drug)
Ibuprofen group
The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy.
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
VAS scores in the postoperative period
时间窗: 24 hour
Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively.
次要结局
- Opioid consumption and length of stay(24 hour)