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

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. Identifier: NCT01274247
Recruitment Status : Terminated (The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.)
First Posted : January 11, 2011
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arm Intervention/treatment
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

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

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01274247

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

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

Keywords provided by Tel-Aviv Sourasky Medical Center:

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