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

NCT ID: NCT01274247

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Tongue-tie Ankyloglossia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical Benzocaine

For infants treated with topical benzocaine prior to the procedure

Group Type ACTIVE_COMPARATOR

Topical Benzocaine

Intervention Type DRUG

Topical administration of a drop of benzocaine to the lingual frenulum

no benzocaine

No benzocaine applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical Benzocaine

Topical administration of a drop of benzocaine to the lingual frenulum

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaul Dollberg, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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Department of Neonatology, Tel AViv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-10-SD-0385-CTIL

Identifier Type: -

Identifier Source: org_study_id