Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 10:12 AM
Study NCT ID:
NCT00521703
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2007-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C000726650', 'term': 'tannic acid'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-22', 'studyFirstSubmitDate': '2007-08-24', 'studyFirstSubmitQcDate': '2007-08-27', 'lastUpdatePostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'propofol dose required to achieve adequate sedation to upper digestive endoscopy', 'timeFrame': 'one hour'}], 'secondaryOutcomes': [{'measure': 'incidence of tachycardia (heart rate > 120) during the procedure', 'timeFrame': 'one hour'}, {'measure': 'incidence of hypoxemia (SpO2 < 94%) during procedure', 'timeFrame': 'one hour'}, {'measure': 'severity of sore throat after the procedure', 'timeFrame': 'up to 2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopy, gastrointestinal', 'lidocaine', 'propofol', 'child', 'adolescent'], 'conditions': ['Dyspepsia', 'Malabsorption Syndrome', 'Gastroesophageal Reflux Disease', 'Abdominal Pain']}, 'descriptionModule': {'briefSummary': 'There is some controversy in the medical literature regarding the effectiveness of topical lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children, deep sedation and general anesthesia are often used to sedate children submitting to this procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this drug can only be used with an anesthesiologist in Brazil. Its main side effects include hypotension, respiratory depression and local pain. Lidocaine is frequently used as premedication, and the rationale is that lowering patient discomfort could lower the required dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients perceive this medication as uncomfortable. This study aims to compare sedative drug doses between patients who were given either placebo or topical lidocaine.', 'detailedDescription': 'This study is a randomized double-blind placebo-controlled clinical trial.\n\nPrimary outcome: propofol doses required to achieve adequate sedation.\n\nPopulation: children submitting to upper digestive endoscopy, weight \\> 30 kg and age between 8 and 18 years.\n\nExclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication to either lidocaine or propofol.\n\nEstimated sample: 160 patients. Placebo: tannic acid 0.5%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years\n\nExclusion Criteria:\n\n* Neurological disorders\n* Psychiatric disorders\n* Specific contra-indication to lidocaine\n* Specific contra-indication to propofol'}, 'identificationModule': {'nctId': 'NCT00521703', 'briefTitle': 'Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Infantil Cândido Fontoura'}, 'officialTitle': 'Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers', 'orgStudyIdInfo': {'id': 'HICF 001-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'group treated', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'control group', 'interventionNames': ['Drug: Tannic acid']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing', 'armGroupLabels': ['1']}, {'name': 'Tannic acid', 'type': 'DRUG', 'description': 'oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04042-004', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Infantil Cândido Fontoura', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rodrigo S Machado, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIFESP/EPM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Infantil Cândido Fontoura', 'class': 'OTHER'}}}}