Maternal Nipple Pain Upon Breastfeeding Clinical Trial
Official title:
Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
| Verified date | August 2012 |
| Source | Tel-Aviv Sourasky Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 21 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 7 Days |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Department of Neonatology, Tel AViv Medical Center | Tel AViv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of cry after lingual frenotomy | 10 minutes | No |