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Completed

NCT Number: NCT01914250

Pain Associated With Neonatal Frenotomy

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

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Key information

Conditions

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

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam HealthCare Campus

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

-

Treatment and study plan

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

Primary outcomes

  1. Neonatal Facial Coding System (NFCS)

    Time frame: During procesure

Secondary outcomes

  1. Cry Duration

    Time frame: Post procedure

Other outcomes

  1. Visual Analog Score (VAS)

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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