Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 11:13 PM
Study NCT ID:
NCT06023368
Status:
WITHDRAWN
Last Update Posted:
2024-11-14
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administrative burden', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Port Access Pain', 'timeFrame': 'Within 5 minutes of port access', 'description': 'Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.'}, {'measure': 'Clinic Wait Time', 'timeFrame': 'Day of visit, up to 8 hours', 'description': 'Wait time will be measured in minutes from check in to check out'}, {'measure': 'Duration of Visit', 'timeFrame': 'Day of visit, up to 8 hours', 'description': 'Total length of overall appointment time measured in minutes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Port access pain', 'pediatric', 'oncology'], 'conditions': ['Pediatric Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.\n\nParticipants will receive either the spray or cream prior to port access and rate pain on a scale.\n\nResearchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English-speaking\n* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy\n* EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment\n* Previous allergic reaction or skin irritation due to EMLA\n* Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy\n\nExclusion Criteria:\n\n* Child has a legal guardian or non-parent family member as the only adult with them for the visit.\n* Children less than 4 years of age\n* Children with altered mental status\n* History of traumatic brain injury, developmental delay or autism\n* Child is nonverbal\n* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect."}, 'identificationModule': {'nctId': 'NCT06023368', 'briefTitle': 'Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray', 'orgStudyIdInfo': {'id': '84569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sterile Vapocoolant Spray', 'description': 'Num vapocoolant spray will be administered as a single use canister around the port', 'interventionNames': ['Drug: Num Vapocoolant Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EMLA Cream', 'description': 'Numbing (EMLA) cream will be applied around the port.', 'interventionNames': ['Drug: EMLA Cream']}], 'interventions': [{'name': 'Num Vapocoolant Spray', 'type': 'DRUG', 'otherNames': ['Vapocoolant Spray'], 'description': 'Spray applied around port prior to access', 'armGroupLabels': ['Sterile Vapocoolant Spray']}, {'name': 'EMLA Cream', 'type': 'DRUG', 'otherNames': ['numbing cream'], 'description': 'cream applied around the port prior to access', 'armGroupLabels': ['EMLA Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky DanceBlue Pediatric Hematology/oncology clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Marianne Hutti, PhD, APRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marianne Hutti', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bimeco Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marianne Hutti', 'investigatorAffiliation': 'University of Kentucky'}}}}