NCT01914250已完成不适用
Pain Associated With Neonatal Frenotomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neonatal Facial Coding System (NFCS)
研究概览
简要总结
The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants diagnosed with ankyloglossia at the nursery of the RHCC, who will be referred by a qualified neonatologist to the OCAD for a routine tongue-tie frenotomy procedure because of breast feeding difficulties.
- •Ankyloglossia type 1 or 2 Exclusion criteria
- •Abnormal oral or nasopharyngeal anatomy
- •Any known congenital malformations
- •Ankyloglossia type 3 or 4
排除标准
- 未提供
研究组 & 干预措施
2
Active Comparator
Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B
干预措施: Analgesic effect of topical tetracaine 2 % (Drug)
结局指标
主要结局
Neonatal Facial Coding System (NFCS)
时间窗: During procesure
次要结局
- Cry Duration(Post procedure)
研究者
研究点 (1)
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