NCT01274247终止1 期
Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Duration of cry after lingual frenotomy
研究概览
简要总结
Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.
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
- None
入排标准
- 年龄范围
- 12 Hours 至 7 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term Newborn infant
- •Tongue-tie upon physical examination
- •Maternal complains of nipple pain or difficult latch
排除标准
- •Abnormal oral or nasopharyngeal anatomy
- •Any known congenital malformations
- •Prematurity
研究组 & 干预措施
Topical Benzocaine
Active Comparator
For infants treated with topical benzocaine prior to the procedure
干预措施: Topical Benzocaine (Drug)
结局指标
主要结局
Duration of cry after lingual frenotomy
时间窗: 10 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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