Pain Associated With Neonatal Frenotomy

Rambam Health Care Campus

Status: Completed

Conditions: Pain

Treatments: Drug: Analgesic effect of topical tetracaine 2 %

Study type: Interventional

Funder types: Other

Identifiers

NCT01914250

01 Dated 01 August 2012

Details and patient eligibility

About

The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 8 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

infants diagnosed with ankyloglossia at the nursery of the RHCC, who will be referred by a qualified neonatologist to the OCAD for a routine tongue-tie frenotomy procedure because of breast feeding difficulties.

• Ankyloglossia type 1 or 2 Exclusion criteria
• Abnormal oral or nasopharyngeal anatomy
• Any known congenital malformations
• Ankyloglossia type 3 or 4

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 1 patient group

2

Active Comparator group

Description:

Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B

Treatment:

Drug: Analgesic effect of topical tetracaine 2 %