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

This study has been terminated.
(The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274247
First Posted: January 11, 2011
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose
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.

Condition Intervention Phase
Neonatal Tongue-tie Maternal Nipple Pain Upon Breastfeeding Neonatal Latch Difficulties Drug: Topical Benzocaine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Duration of cry after lingual frenotomy [ Time Frame: 10 minutes ]

Enrollment: 21
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical Benzocaine
For infants treated with topical benzocaine prior to the procedure
Drug: Topical Benzocaine
Topical administration of a drop of benzocaine to the lingual frenulum
No Intervention: no benzocaine
No benzocaine applied

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274247


Locations
Israel
Department of Neonatology, Tel AViv Medical Center
Tel AViv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shaul Dollberg, MD Tel Aviv Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01274247     History of Changes
Other Study ID Numbers: TASMC-10-SD-0385-CTIL
First Submitted: January 10, 2011
First Posted: January 11, 2011
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
Tongue-tie
Ankyloglossia

Additional relevant MeSH terms:
Ankyloglossia
Stomatognathic Diseases
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents