Use of Topical Benzocaine for Analgesia in Lingual Frenot... | NCT01274247

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

NCT01274247

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Terminated

Last Update Posted

Aug 2, 2012Estimated

Enrollment

21Actual

Phase

Phase 1Phase 2

Conditions

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

Interventions

Topical Benzocaine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2012

Last Update Posted Date

Aug 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Topical Benzocaine	Drug	Topical administration of a drop of benzocaine to the lingual frenulum	Topical Benzocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of cry after lingual frenotomy		10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Hours

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaul Dollberg, MD	Tel Aviv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neonatology, Tel AViv Medical Center		Tel Aviv		64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000072676	Ankyloglossia

Ancestor Terms

ID	Term
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001566	Benzocaine

Ancestor Terms

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided