ClinicalTrials.Veeva

Menu

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

T

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems