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临床试验/NCT01297829
NCT01297829Unknown3 期

Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial

St. Barnabas Medical Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
51
试验地点
1
主要终点
Postoperative Narcotic Use

研究概览

简要总结

Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.

The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.

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, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary inguinal and/or umbilical hernia repair
  • age > 18 years old

排除标准

  • history of gastrointestinal bleeding
  • allergy to ibuprofen
  • creatinine > 1.5 mg/dL

研究组 & 干预措施

IV Caldolor

Active Comparator

干预措施: Intravenous Ibuprofen (Drug)

Placebo

Placebo Comparator

干预措施: IV Placebo (Other)

结局指标

主要结局

Postoperative Narcotic Use

时间窗: 7 days

Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.

次要结局

  • Postoperative Visual Analog Pain Scale(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronald S. Chamberlain

Chairman and Chief Department of Surgery

St. Barnabas Medical Center

研究点 (1)

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