Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-01 @ 7:37 AM
Study NCT ID:
NCT01914250
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2013-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Associated With Neonatal Frenotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-25', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-08-01', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Analog Score (VAS)', 'timeFrame': 'During procedure'}], 'primaryOutcomes': [{'measure': 'Neonatal Facial Coding System (NFCS)', 'timeFrame': 'During procesure'}], 'secondaryOutcomes': [{'measure': 'Cry Duration', 'timeFrame': 'Post procedure'}]}, 'conditionsModule': {'keywords': ['Frenotomy', 'Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '28204733', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ninfants 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.\n\n* Ankyloglossia type 1 or 2 Exclusion criteria\n* Abnormal oral or nasopharyngeal anatomy\n* Any known congenital malformations\n* Ankyloglossia type 3 or 4\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01914250', 'briefTitle': 'Pain Associated With Neonatal Frenotomy', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': '01 Dated 01 August 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B', 'interventionNames': ['Drug: Analgesic effect of topical tetracaine 2 %']}], 'interventions': [{'name': 'Analgesic effect of topical tetracaine 2 %', 'type': 'DRUG', 'description': "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", 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam HealthCare Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Dror - Aizenbud, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chairman Craniofecial Department, Rambam Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}