Pain Associated With Neonatal Frenotomy

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914250
• Other study ID #: 01 Dated 01 August 2012
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: December 25, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Analgesic effect of topical tetracaine 2 %
The patient will be held by the parents and comforted after local anesthesia is applied by a research investigator. Then, he will be placed on procedure's board repositioned for clipping, restrained by the parent/nurse (holding both head and arms, keeping with conventional practice). Exactly 5 minutes after the topical anesthetic was applied, the pediatric dentist will press down the chin gently straddling the frenulum while and holding it in place with visualization of tongue base. Then the frenulum will be snipped along the underside of the tongue to its base. The area will be checked to ensure complete release. Bleeding will be controlled by pressuring with a 2x2 gauze pad under the tongue. A study investigator will film the procedure using GO PRO Video Camera mounted on the forehead of the pediatric dentist

Locations

Country	Name	City	State
Israel	Rambam HealthCare Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Score (VAS)		During procedure	No
Primary	Neonatal Facial Coding System (NFCS)		During procesure	No
Secondary	Cry Duration		Post procedure	No