Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-04-06 @ 10:27 AM
Study NCT ID:
NCT02205502
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2014-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine as Local Anesthetics in Children Under Ketamine Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-06', 'studyFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Hospital of Eastern Ontario Pain Scale (CHEOPS", 'timeFrame': 'up to 1 hour', 'description': "The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound."}], 'secondaryOutcomes': [{'measure': 'Sedation scale', 'timeFrame': 'up to 1 hour', 'description': 'The investigators will measure sedation scale with Ramsey Sedation Scale.'}, {'measure': 'Complication', 'timeFrame': 'up to 1 hour', 'description': 'The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.'}, {'measure': 'Satisfaction of parents and clinicians', 'timeFrame': 'up to 1 hour', 'description': "The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Conscious Sedation Failure During Procedure', 'Analgesia', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Ketamine seems an obvious choice in the setting of an emergency department in laceration repair.\n\nLidocaine is the local anesthetics widespread used.\n\nKetamine leads to dissociative amnesia.\n\nTheoretically , lidocaine is not useful in laceration repair using ketamine.\n\nHowever, lidocaine is used with ketamine in many emergency department.\n\nThe investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who need suturing for laceration under procedural anesthesia using ketamine\n\nExclusion Criteria:\n\n* contraindication to ketamine and lidocaine\n* patients involved to other studies\n* more or equal to American Society of Anesthesiologist (ASA) class III\n* not alert'}, 'identificationModule': {'nctId': 'NCT02205502', 'briefTitle': 'Lidocaine as Local Anesthetics in Children Under Ketamine Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine', 'orgStudyIdInfo': {'id': 'Lidocaine-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Proper amount of lidocaine will be injected lacerated wound.\n\n* dosage form: fluid\n* dosage: not exceeding 1mg/kg\n* frequency: once\n* duration: n/a', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline will be used as a placebo for lidocaine', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Normal saline', 'type': 'DRUG', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Hee Lee, Professor', 'role': 'CONTACT', 'email': 'gienee74@gmail.com', 'phone': '+82-31-787-7586'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Jin Hee Lee, Professor', 'role': 'CONTACT', 'email': 'gienee@snubh.org', 'phone': '+82-31-787-7575'}], 'overallOfficials': [{'name': 'Jin Hee Lee, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Jin Hee Lee,, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jin Hee Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}