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

Phase 1

Terminated

• Conditions: Neonatal Tongue-tie; Maternal Nipple Pain Upon Breastfeeding; Neonatal Latch Difficulties
• Interventions: Drug: Topical Benzocaine

• Registration Number: NCT01274247
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Study Start: 2011-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Benzocaine	Topical Benzocaine	For infants treated with topical benzocaine prior to the procedure

Primary Outcome Measures

Name	Time	Method
Duration of cry after lingual frenotomy	10 minutes

Trial Locations

Locations (1)

Department of Neonatology, Tel AViv Medical Center; 🇮🇱 Tel AViv, Israel