Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Tongue-tie; Maternal Nipple Pain Upon Breastfeeding; Neonatal Latch Difficulties
Intervention: Topical Benzocaine (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Tel-Aviv Sourasky Medical Center Official(s) and/or principal investigator(s):
Shaul Dollberg, MD, Principal Investigator, Affiliation: Tel Aviv Medical Center
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of cry after lingual frenotomy
Eligibility
Minimum age: N/A.
Maximum age: 7 Days.
Gender(s): Both.
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
Locations and Contacts
Department of Neonatology, Tel AViv Medical Center, Tel AViv 64239, Israel
Additional Information
Starting date: February 2011
Last updated: August 1, 2012
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