NCT04771156招募中4 期
Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年9月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Volume of oral intake
研究概览
简要总结
The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
排除标准
- •Syndromic Cleft Palate patients
- •Previous palatoplasty
- •Major unrepaired cardiac malformation
- •History of GI complications (GI Bleed, Gastric Ulceration)
- •History of Renal disorder
- •History of coagulopathy (As contraindication to NSAID use)
- •Feeding tube dependency
- •Patients whose parents refuse to consent to randomization
研究组 & 干预措施
Experimental group (Ketorolac)
Experimental
干预措施: Ketorolac (Drug)
Control Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Volume of oral intake
时间窗: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery
This will be measured in mL's of fluids
次要结局
- Pain as assessed by the Faces scale(7 days post discharge)
- Time to first oral intake(within 24 hours post surgery)
- Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)(7 days post surgery)
- Renal function measured in mL/kg of urine output(from arrival to PACU to discharge (24-48 hours post surgery))
- Number of participants with post operative complications(30 days post surgery)
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale(48 hours post surgery)
- Number of participants who need narcotic prescription at discharge(at discharge(24-48 hours post surgery))
- Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room(24 hours and 48 hours after surgery)
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale(immediately upon arrival at PACU)
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale(24 hours post surgery)
研究者
Matthew Greives
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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