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

Tel Aviv Sourasky Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Maternal Nipple Pain Upon Breastfeeding; Neonatal Tongue-tie; Neonatal Latch Difficulties

Treatments: Drug: Topical Benzocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01274247

TASMC-10-SD-0385-CTIL

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 12 hours to 7 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Topical Benzocaine

Active Comparator group

Description:

For infants treated with topical benzocaine prior to the procedure

Treatment:

Drug: Topical Benzocaine

no benzocaine

No Intervention group

Description:

No benzocaine applied