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

Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Tongue-tie; Maternal Nipple Pain Upon Breastfeeding; Neonatal Latch Difficulties

Intervention: Topical Benzocaine (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Tel-Aviv Sourasky Medical Center

Official(s) and/or principal investigator(s):
Shaul Dollberg, MD, Principal Investigator, Affiliation: Tel Aviv Medical Center


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Duration of cry after lingual frenotomy


Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.


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 and Contacts

Department of Neonatology, Tel AViv Medical Center, Tel AViv 64239, Israel
Additional Information

Starting date: February 2011
Last updated: August 1, 2012

Page last updated: August 23, 2015

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