NCT01274247

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

January 10, 2011

Last Update Submit

August 1, 2012

Conditions

Neonatal Tongue-tieMaternal Nipple Pain Upon BreastfeedingNeonatal Latch Difficulties

Keywords

Tongue-tieAnkyloglossia

Outcome Measures

Primary Outcomes (1)

  • Duration of cry after lingual frenotomy

    10 minutes

Study Arms (2)

Topical Benzocaine

ACTIVE COMPARATOR

For infants treated with topical benzocaine prior to the procedure

Drug: Topical Benzocaine

no benzocaine

NO INTERVENTION

No benzocaine applied

Interventions

Topical BenzocaineDRUG

Topical administration of a drop of benzocaine to the lingual frenulum

Topical Benzocaine

Eligibility Criteria

Age12 Hours - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full term Newborn infant
  • Tongue-tie upon physical examination
  • Maternal complains of nipple pain or difficult latch

You may not qualify if:

  • Abnormal oral or nasopharyngeal anatomy
  • Any known congenital malformations
  • Prematurity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology, Tel AViv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Ankyloglossia

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Shaul Dollberg, MD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

IL(1)