Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 12:17 PM
Study NCT ID:
NCT00643032
Status:
UNKNOWN
Last Update Posted:
2008-03-25
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Anxiety and Postoperative Pain in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-19', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Post-Operative Pain', 'Pre-Operative Anxiety']}, 'descriptionModule': {'briefSummary': 'We wish to study which method of local injection of analgesic (before or during surgery) is the more effective method to reduce post-operative pain in children. In addition, we wish to study which pre-operative educational intervention is more effective in reducing anxiety in children and their family.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* ASA I - II\n* Undergoing elective day surgery\n\nExclusion Criteria:\n\n* Known coagulation dysfunction\n* Sensitivity to analgesics'}, 'identificationModule': {'nctId': 'NCT00643032', 'briefTitle': 'Preoperative Anxiety and Postoperative Pain in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Comparison of 2 Methods to Reduce Postoperative Pain in Children and a Comparison of 3 Methods of Preoperative Education Intervention to Reduce Anxiety in Children and Their Family', 'orgStudyIdInfo': {'id': '50/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'interventionNames': ['Procedure: Transcutaneous iliohypogastric']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'interventionNames': ['Procedure: Perioperative administration near the nerve']}], 'interventions': [{'name': 'Transcutaneous iliohypogastric', 'type': 'PROCEDURE', 'armGroupLabels': ['I']}, {'name': 'Perioperative administration near the nerve', 'type': 'PROCEDURE', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Reuma Barkan', 'role': 'CONTACT', 'email': 'reuma@hy.health.gov.il'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Zvi Steiner, MD', 'role': 'CONTACT', 'email': 'steiner@hy.health.gov.il', 'phone': '972-4-6304434'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Zvi Steiner', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}