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临床试验/NCT01274247
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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年2月最近更新:
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

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

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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