A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- VAS Scores.
研究概览
简要总结
Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery.
详细描述
Block randomization will be used to randomize patients to one of two combinations. Group A will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules are placed in identical dossettes containing a seven day supply. Patients are instructed to start taking their medications post-op and continue until they are pain free. All participants are given a series of blank Visual Analogue scales and Likert scales and instructed to record their level of pain intensity and pain relief four times per day for the entire week. Peri-operative pain management will be standardized. Patients will not receive pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as selected by anaesthesiology. No local/regional anaesthesia will be used. Intravenous ketorolac will not be allowed for trial participants. All patients will receive intravenous opioid and anti-emetic if required in PACU. Any patients with peri-operative complications or other problems requiring admission or alternative analgesics will be excluded.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 to 70 inclusive
- •outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
排除标准
- •allergies to acetaminophen, NSAIDs, ASA or codeine.
- •recent reported history of upper GI bleeding.
- •daily analgesic use (OTC or opioid) pre-operatively.
- •any opioid use in the week prior to surgery.
- •reported history of PUD if not on PPI regularly.
- •anticoagulant use (low dose ASA excepted).
- •renal disease or impairment.
- •reported history of liver disease.
- •pregnancy.
- •major operative complications.
- •patients requiring admission.
- •communication barrier.
- •cognitive or memory impairment.
- •reported history of drug and/or alcohol abuse.
研究组 & 干预措施
1
干预措施: acetaminophen plus codeine (Drug)
2
干预措施: acetaminophen plus ibuprofen (Drug)
结局指标
主要结局
VAS Scores.
时间窗: mean and daily
maximum VAS scores.
时间窗: daily
Likert scores.
时间窗: mean daily and final
Patient satisfaction with analgesic regimen.
时间窗: day 7
Treatment failures-inadequate pain relief or inability to tolerate side effects.
时间窗: daily
Time to stopping medication.
时间窗: day 7
次要结局
- Compliance with regimen.(day 7)
- Total Pain relief (TOTPAR).(daily)
- Sum of pain intensity differences (SPID).(day7)
- Amount of medication used.(day 7)
- Incidence of side effects.(day 7)