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

Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274247

Enrollment

Registered

2011-01-11

Start date

2011-02-28

Completion date

2012-06-30

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Tongue-tie, Ankyloglossia

Brief summary

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.

Interventions

DRUGTopical Benzocaine

Topical administration of a drop of benzocaine to the lingual frenulum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Hours to 7 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Duration of cry after lingual frenotomy	10 minutes

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026