Pain Associated With Neonatal Frenotomy

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Pain
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

Trial Locations (1)

Unknown

Rambam HealthCare Campus, Haifa

All Listed Sponsors
lead

Rambam Health Care Campus

OTHER

NCT01914250 - Pain Associated With Neonatal Frenotomy | Biotech Hunter | Biotech Hunter