Pain Associated With Neonatal Frenotomy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Analgesic effect of topical tetracaine 2 %

• Registration Number: NCT01914250
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-25
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Analgesic effect of topical tetracaine 2 %	Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B

Primary Outcome Measures

Name	Time	Method
Neonatal Facial Coding System (NFCS)	During procesure

Secondary Outcome Measures

Name	Time	Method
Cry Duration	Post procedure

Trial Locations

Locations (1)

Rambam HealthCare Campus; 🇮🇱 Haifa, Israel