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临床试验/NCT02465138
NCT02465138撤回4 期

A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

University of California, San Francisco2 个研究点 分布在 1 个国家开始时间: 2023年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Number of participants with adverse events

研究概览

简要总结

Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis. Determine if IV ketorolac provides improved post-procedure analgesia.

Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.

详细描述

Acute pancreatitis is the most common major complication of both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity and an annual expenditure of approximately 150 million annually.(1,2) Non-steroidal anti-inflammatory agents (NSAIDs) have been shown to be effective in multiple prospective randomized controlled trial for the prevention of post-ERCP pancreatitis.(3-6) NSAIDs are postulated to inhibit phospholipase A2 and prostaglandin synthesis, which plays an important role in the inflammatory cascade in acute pancreatitis. Rectal suppository indomethacin (a potent COX-2 inhibitor) has been effective in preventing post-ERCP pancreatitis in clinical trials and is now recommended for routine use for ERCP by the European Society of Gastrointestinal Endoscopy.(7) Toradol® (ketorolac), an NSAID available in IV form, is a more potent COX-2 inhibitor and analgesic than indomethacin.(8,9) Ketorolac is routinely used postoperatively following major surgery to assist in pain control particularly following orthopedic procedures. IV ketorolac has never been evaluated for the prevention of post-ERCP pancreatitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients presenting to SFGH for ERCP
  • Age 18-85
  • Do not meet exclusion criteria

排除标准

  • Acute pancreatitis at the time of ERCP
  • Use of NSAIDs in the previous week
  • Peptic ulcer disease
  • Severe renal dysfunction
  • Pregnancy
  • Lithium therapy
  • allergy to ketorolac

研究组 & 干预措施

Toradol

Active Comparator

Intravenous ketorolac prior to ERCP

干预措施: Ketorolac (Drug)

Placebo

Placebo Comparator

Normal Saline will be administered prior to procedure.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of participants with adverse events

时间窗: 5 days after ERCP procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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