Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
研究概览
简要总结
In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.
详细描述
Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing arthroscopic meniscectomy were included in the study.
排除标准
- •≤ 18 years of age
- •hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
- •history of peptic ulcer, gastritis, upper gastrointestinal bleeding
- •coagulation disorder
- •serious hepatic and renal impairment
- •pregnancy
- •long-term NSAID and opioid use
研究组 & 干预措施
Group Naproxen sodium (Group N)
Group N received naproxen sodium 550 mg 60 minutes before surgery.
干预措施: Group N:Naproxen sodium (Drug)
Group Naproxen sodium codeine phosphate (Group NC)
Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery.
干预措施: Group NC :naproxen sodium codeine phosphate (Drug)
结局指标
主要结局
Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
时间窗: postoperative 18 hours
patients will be followed postoperatively 18 hours for pain levels
次要结局
未报告次要终点
研究者
CAGLA BALI,MD
MD,Anesthesiology and Reanimation
Baskent University