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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:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01274247
First received: January 10, 2011
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  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: 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:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov 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:
Tongue-tie
Ankyloglossia

Additional relevant MeSH terms:
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013