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临床试验/NCT03131713
NCT03131713已完成3 期

Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers

Tufts Medical Center1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
101
试验地点
1
主要终点
Maximum Pain Score

研究概览

简要总结

The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

排除标准

  • history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen

研究组 & 干预措施

Intervention

Experimental

The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Maximum Pain Score

时间窗: Day of surgery

Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.

次要结局

  • Anxiety(Day of surgery)
  • Thirst(Day of surgery)
  • Number of Participants Using Post-operative Analgesic(48 hours after surgery)
  • Hunger(Day of surgery)
  • Fatigue(Day of surgery)
  • Maximum Post-op Pain Score(48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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