Pain Associated With Neonatal Frenotomy

NCT01914250 | Completed

• 1 other identifier: 01 Dated 01 August 2012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Frenotomy; Pain

Outcome Measures

Primary Outcomes (1)

• Neonatal Facial Coding System (NFCS)

  During procesure

Secondary Outcomes (1)

• Cry Duration

  Post procedure

Other Outcomes (1)

• Visual Analog Score (VAS)

  During procedure

Study Arms (1)

2

ACTIVE COMPARATOR

Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B

Drug: Analgesic effect of topical tetracaine 2 %

Interventions

Analgesic effect of topical tetracaine 2 % DRUG

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

2

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Abnormal oral or nasopharyngeal anatomy
• Any known congenital malformations
• Ankyloglossia type 3 or 4

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam HealthCare Campus

Haifa, Israel

Location

Related Publications (1)

• Shavit I, Peri-Front Y, Rosen-Walther A, Grunau RE, Neuman G, Nachmani O, Koren G, Aizenbud D. A Randomized Trial to Evaluate the Effect of Two Topical Anesthetics on Pain Response During Frenotomy in Young Infants. Pain Med. 2017 Feb 1;18(2):356-362. doi: 10.1093/pm/pnw097.

  PMID: 28204733 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dror - Aizenbud, Professor

  Chairman Craniofecial Department, Rambam Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: August 2, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

IL (1)