Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-08 @ 1:47 AM
Study NCT ID:
NCT02519660
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 339}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2015-08-07', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success at the first attempt', 'timeFrame': 'Intraoperative', 'description': 'Percentage of success at first attempt'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Intraoperative', 'description': 'The pain during the procedure will be evaluate using pain rating scale appropriate for age'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 15 minutes after the procedure', 'description': 'The number and the type of adverse events will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ralydan', 'EMLA cream', 'Procedural pain', 'Phlebotomy', 'Child'], 'conditions': ['Procedural Pain Relief']}, 'descriptionModule': {'briefSummary': "Needle-related procedures are among the most common sources of pain and distress for children in the health care setting. More than 50% of children reported pain during these procedures. The necessity for pain management during these procedures is well established. Topical anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This is the major limitation for its use in emergency settings.\n\nRalydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its application. Only one randomized controlled trial compared the two topical anaesthetics in children during venipuncture and showed that Ralydan patch led to superior analgesia than EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes before needle procedure. No differences were found in success rate of the procedure and vein visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after 60 minutes from application.\n\nTo the best of the investigators' knowledge there is no published study that compared needle procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.\n\nThe aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the first attempt and pain relief in children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 3 to 10 years\n* Need for peripheral IV line or venipuncture\n* Informed consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Need for emergency care\n* Known allergy or sensitivity to local anesthetics'}, 'identificationModule': {'nctId': 'NCT02519660', 'briefTitle': 'Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC 6/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine/Tetracaine patch (Ralydan)', 'description': 'Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. It is applied in the site of venipuncture 30 minutes before needle procedure', 'interventionNames': ['Drug: Lidocaine/Tetracaine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine/Prilocaine cream (EMLA)', 'description': 'EMLA cream is an eutectic mixture of local anaesthetic (lidocaine, prilocaine). It is applied in the site of venipuncture 60 minutes before needle procedure', 'interventionNames': ['Drug: Lidocaine/Prilocaine cream']}], 'interventions': [{'name': 'Lidocaine/Tetracaine patch', 'type': 'DRUG', 'otherNames': ['Ralydan'], 'armGroupLabels': ['Lidocaine/Tetracaine patch (Ralydan)']}, {'name': 'Lidocaine/Prilocaine cream', 'type': 'DRUG', 'otherNames': ['EMLA'], 'armGroupLabels': ['Lidocaine/Prilocaine cream (EMLA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80121', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '34137', 'city': 'Trieste', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '35100', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Egidio Barbi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Burlo Garofolo, Trieste, Italy'}, {'name': 'Elena Neri, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Burlo Garofolo, Trieste, Italy'}, {'name': 'Giorgio Cozzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Burlo Garofolo, Trieste, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ronfani Luca', 'investigatorAffiliation': 'IRCCS Burlo Garofolo'}}}}