An interventional study of Analgesic effect of topical tetracaine 2 % in Pain, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged Up to 8 Weeks. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Diagnostic
The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.
Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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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.
Exclusion Criteria:
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Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B
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
Neonatal Facial Coding System (NFCS)
Time frame: During procesure
Cry Duration
Time frame: Post procedure
Visual Analog Score (VAS)
Time frame: During procedure
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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