Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05957718
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2023-07-15', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wong-Baker Scale Pain', 'timeFrame': '2-3 min. after procedure', 'description': "Was used to measure Children's pain scale"}], 'secondaryOutcomes': [{'measure': 'Child Fear Scale', 'timeFrame': '2-3 min. after procedure', 'description': "Was used to measure Children's fear scale"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Fear of Pain', 'Venipuncture Site Numbness']}, 'descriptionModule': {'briefSummary': 'Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Therefore, implementing effective pain management strategies during venipuncture is crucial to ensure patient comfort and improve the overall healthcare experience. This comprehensive overview aims to highlight the significance of pain management during venipuncture procedures.\n\nThis study will investigate the effects of a pharmacological approach on the pain that children experience during venipuncture in a randomized trial.\n\nTKTX topical anesthetic cream is a new commercially available product. In this study, the cream will be used for a shorter period of time than other creams used in previous studies, and it will also be free of side effects as they have been in previous studies with other creams.', 'detailedDescription': 'Venipuncture is a common medical procedure involving the insertion of a needle into a vein, often causing discomfort and pain. To alleviate this pain, pharmacological approaches have been widely explored. The efficacy of these approaches in managing venipuncture-related pain is of utmost importance for both healthcare professionals and patients. Various pharmacological options have been studied, including topical anesthetics such as lidocaine creams or patches, local anesthetic injections like buffered lidocaine or ethyl chloride spray, and systemic analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.\n\nYou may experience some pain, often a brief sting, when the needle is inserted into and removed from your arm.\n\nNon-pharmacological pain intervention is a prophylactic and complementary approach to reduce pain.\n\nEnsuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance.\n\nPharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA (r), amethocaine and lidocaine.\n\nEvaluating the effectiveness of these interventions requires considering factors like onset and duration of action, adequate pain relief achieved, patient satisfaction levels, and potential adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* School-age Children and\n* Required needle procedures\n\nExclusion Criteria:\n\n* Neurodevelopmental problems\n* Chronic disease\n* Taken Analgesic'}, 'identificationModule': {'nctId': 'NCT05957718', 'briefTitle': 'Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Sherzad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TKTX Group', 'description': 'In this group, We will use TKTX cream as a local anesthesia', 'interventionNames': ['Drug: TKTX cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'In this group, we will use a Vasalin as Placebo', 'interventionNames': ['Drug: TKTX cream']}], 'interventions': [{'name': 'TKTX cream', 'type': 'DRUG', 'otherNames': ['Placebo (Vasaline)'], 'description': 'TKTX cream was used in several studies on Tatto and laser', 'armGroupLabels': ['Control Group', 'TKTX Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42012', 'city': 'Dihok', 'country': 'Iraq', 'facility': 'Sherzad Khudeida Suleman', 'geoPoint': {'lat': 36.86608, 'lon': 42.9879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}