A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.
详细描述
Subjects were enrolled following the listed inclusion and exclusion criteria.
Subjects Eligibility Criteria:
Inclusion Criteria:
Male and female patients ASA I - III . 18 years of age and older
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older
- •Patient must be scheduled for laparoscopic cholecystectomy
排除标准
- •Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery
- •Chronic home narcotic use (patient-reported narcotic use for greater than 3 months)
- •Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery
- •Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery
- •Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery)
- •Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours
- •Use of intraoperative NSAIDs
- •Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components;
- •On a medication with known interactions with acetaminophen
- •On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day
- •Pregnancy
- •Current or past alcohol abuse (within the past 2 years)
研究组 & 干预措施
Group 1
Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules "sugar pills" 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
干预措施: IV tylenol 1000mg and 2 oral capsule "sugar pills" (Drug)
Group 2
Group 2 will receive an IV "salt water" infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
干预措施: 2 capsules Oral Tylenol 2000 mg and IV "salt water" (Drug)
结局指标
主要结局
Pain
时间窗: 24 hours after discharge
Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.
次要结局
- Total Opioid Consumption From Time of First Waking to T24(every 6 hours for 24 hours)