NCT00161577已完成4 期
Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Total morphine administered
研究概览
简要总结
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.
详细描述
Current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. The investigators hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females > 18 years of age at the screening visit.
- •Undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass.
- •American Society of Anesthesiology (ASA) Physical Class 3, or
- •Willing able to use a PCA Pump
- •Willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain.
- •Capable of speaking and understanding English sufficiently to provide written informed consent and responses to pain assessment scales and neurological questionnaires.
排除标准
- •Allergy or sensitivity to nonsteroidal anti-inflammatory drugs
- •History of gastrointestinal bleeding or peptic ulcer
- •Serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with Dialysis Dependent End Stage Renal Disease (ESRD).
- •Hepatic dysfunction
- •Patients with low cardiac output syndrome (cardiac index < 2.0) after cardiopulmonary bypass or pre-op ejection fraction < 30%
- •Inability to operate PCA pump
- •Cardiothoracic reoperations
- •Bleeding disorder
研究组 & 干预措施
B
Placebo Comparator
干预措施: Placebo (Other)
A
Other
Group A = Ketorolac
干预措施: Ketorolac (Drug)
结局指标
主要结局
Total morphine administered
时间窗: 24 hours post operatively
次要结局
- Chest tube drainage(24 hours post operatively)
- Respiratory Assessments (NIF, VC)(24 hours post operatively)
- VAS Pain Scale(24 hours post operatively)
研究者
研究点 (1)
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