Status:

COMPLETED

Pain Associated With Neonatal Frenotomy

Lead Sponsor:

Rambam Health Care Campus

Conditions:

Pain

Eligibility:

All Genders

Up to 8 years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2014

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01914250

Start Date

January 1 2013

End Date

December 1 2014

Last Update

December 30 2014

Active Locations (1)

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1

Rambam HealthCare Campus

Haifa, Israel