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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.)
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: January 10, 2011
Last updated: August 1, 2012
Last verified: August 2012
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: 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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   up to 7 Days   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01274247     History of Changes
Other Study ID Numbers: TASMC-10-SD-0385-CTIL 
Study First Received: January 10, 2011
Last Updated: August 1, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 21, 2016