A Phase 1/2 interventional study of Topical Benzocaine in Neonatal Tongue-tie, Maternal Nipple Pain Upon Breastfeeding and Neonatal Latch Difficulties, sponsored by Tel-Aviv Sourasky Medical Center. Terminated at 1 site in Israel. Open to participants aged 12 Hours to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-02.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 1/2, Interventional, and Treatment
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.
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This study's enrollment of 21 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.
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Exclusion Criteria:
For infants treated with topical benzocaine prior to the procedure
Drug: Topical Benzocaine
No benzocaine applied
Topical administration of a drop of benzocaine to the lingual frenulum
Duration of cry after lingual frenotomy
Time frame: 10 minutes
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Studies of the drug tested here: Benzocaine
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