- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274247
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
August 1, 2012 updated by: Tel-Aviv Sourasky Medical Center
Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel AViv, Israel, 64239
- Department of Neonatology, Tel AViv Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Topical Benzocaine
For infants treated with topical benzocaine prior to the procedure
|
Topical administration of a drop of benzocaine to the lingual frenulum
|
No Intervention: no benzocaine
No benzocaine applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of cry after lingual frenotomy
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shaul Dollberg, MD, Tel Aviv Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
January 10, 2011
First Posted (Estimate)
January 11, 2011
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-10-SD-0385-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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