NCT01332253已完成3 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
Cumberland Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
研究概览
简要总结
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.
排除标准
- •Have inadequate intravenous access
- •Patients with significant cognitive impairment
- •Active, clinically significant asthma
- •History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
- •Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
- •Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
- •Have taken investigational drugs within 30 days before clinical trial material administration.
- •Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Surrogates will be needed for most patients.
- •Refusal to provide written authorization for use and disclosure of protected health information.
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
研究组 & 干预措施
Intravenous Ibuprofen
Experimental
干预措施: Intravenous ibuprofen (Drug)
Normal Saline
Placebo Comparator
干预措施: Normal Saline (Other)
结局指标
主要结局
Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
时间窗: 4 hours
To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.
次要结局
- Time to Swallow Post Procedure.(every 15 minutes until able to swallow)
- Parent Satisfaction With Regards to Pain Management Post Procedure.(Discharge)
- Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.(30 minutes post-procedure)
- Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.(120 minutes post-procedure)
- Time to Discharge Post Procedure.(Discharge)
- Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.(60 minutes post-procedure)
- Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.(90 minutes post-procedure)
- Parental Satisfaction With Vomiting Control in the Post-Operative Period.(Discharge)
- Parent Satisfaction With Regards to Nausea Management Post Procedure.(Discharge)
- Blood Loss During Surgery(End of Surgery)
研究者
研究点 (6)
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