NCT01914250

Pain Associated With Neonatal Frenotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 8 Weeks
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-08-02
• Last updated: 2014-12-30

Locations

1 site across 1 country: Israel