Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn

Phase 2TerminatedNCT01274247

Tel-Aviv Sourasky Medical Center21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neonatal Tongue-tie Maternal Nipple Pain Upon Breastfeeding Neonatal Latch Difficulties

Interventions

Topical administration of a drop of benzocaine to the lingual frenulum

Eligibility

Sex: ALLMin age: 12 HoursMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Full term Newborn infant * Tongue-tie upon physical examination * Maternal complains of nipple pain or difficult latch Exclusion Criteria: * Abnormal oral or nasopharyngeal anatomy * Any known congenital malformations * Prematurity

Locations (1)

Department of Neonatology, Tel AViv Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Duration of cry after lingual frenotomy

Time frame: 10 minutes

Data from ClinicalTrials.gov

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