TerminatedPhase 1/2

Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn

Stopped: The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.

Israel21 participantsStarted 2011-02

Plain-language summary

Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.

Who can participate

Age range

12 Hours – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Full term Newborn infant * Tongue-tie upon physical examination * Maternal complains of nipple pain or difficult latch Exclusion Criteria: * Abnormal oral or nasopharyngeal anatomy * Any known congenital malformations * Prematurity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of cry after lingual frenotomy

Timeframe: 10 minutes

Trial details

NCT IDNCT01274247

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Neonatal Tongue-tie trials