Back to resultsUse of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
Primary Purpose
Neonatal Tongue-tie, Maternal Nipple Pain Upon Breastfeeding, Neonatal Latch Difficulties
Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Topical Benzocaine
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Tongue-tie focused on measuring Tongue-tie, Ankyloglossia
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
Sites / Locations
- Department of Neonatology, Tel AViv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Topical Benzocaine
no benzocaine
Arm Description
For infants treated with topical benzocaine prior to the procedure
No benzocaine applied
Outcomes
Primary Outcome Measures
Duration of cry after lingual frenotomy
Secondary Outcome Measures
Full Information
NCT ID
NCT01274247
First Posted
January 10, 2011
Last Updated
August 1, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01274247
Brief Title
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Tongue-tie, Maternal Nipple Pain Upon Breastfeeding, Neonatal Latch Difficulties
Keywords
Tongue-tie, Ankyloglossia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Benzocaine
Arm Type
Active Comparator
Arm Description
For infants treated with topical benzocaine prior to the procedure
Arm Title
no benzocaine
Arm Type
No Intervention
Arm Description
No benzocaine applied
Intervention Type
Drug
Intervention Name(s)
Topical Benzocaine
Intervention Description
Topical administration of a drop of benzocaine to the lingual frenulum
Primary Outcome Measure Information:
Title
Duration of cry after lingual frenotomy
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaul Dollberg, MD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology, Tel AViv Medical Center
City
Tel AViv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
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