Pain
Conditions
Keywords
Frenotomy, Pain
Brief summary
The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.
Interventions
DRUGAnalgesic 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
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal Facial Coding System (NFCS) | During procesure |
Secondary
| Measure | Time frame |
|---|---|
| Cry Duration | Post procedure |
Other
| Measure | Time frame |
|---|---|
| Visual Analog Score (VAS) | During procedure |
Countries
Israel
Outcome results
None listed