Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Oral Intake in ml/kg
研究概览
简要总结
The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥6 months and ≤5 years old
- •Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease
- •History of decreased oral fluid intake by parent or guardian
- •English or Spanish speaking parents or guardians
排除标准
- •Severely dehydrated or toxic, requiring immediate resuscitation
- •Exclusively breastfed
- •Severe dental disease
- •Significant mouth trauma
- •Active Malignancy
- •Preexisting upper airway obstruction or swallowing difficulties
- •Received intravenous fluids within 24 hours
- •Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours of enrollment
研究组 & 干预措施
Experimental Group
Subjects will receive sucralfate
干预措施: Sucralfate (Drug)
Experimental Group
Subjects will receive sucralfate
干预措施: Acetaminophen (Drug)
Experimental Group
Subjects will receive sucralfate
干预措施: Ibuprofen (Drug)
Placebo Group
Subjects will receive a placebo
干预措施: Placebo (Other)
Placebo Group
Subjects will receive a placebo
干预措施: Acetaminophen (Drug)
Placebo Group
Subjects will receive a placebo
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Oral Intake in ml/kg
时间窗: Approximately 60 minutes after medication administration.
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
次要结局
- Number of Participants That Require Intravenous Fluid Administration(6 hours from the time of enrollment)
- Number of Participants That Require Admission(6 hours from the time of enrollment)
- Number of Participants With Unscheduled Visits(Approximately 72 hours from ED visit)
研究者
Nidhi Vaidya
Resident
University of Texas at Austin