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Pain Associated With Neonatal Frenotomy

NCT01914250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-12-30

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Dror - Aizenbud, Professor · Chairman Craniofecial Department, Rambam Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01914250 on ClinicalTrials.gov