Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-06 @ 8:04 AM
Study NCT ID:
NCT02773602
Status:
UNKNOWN
Last Update Posted:
2016-05-16
First Post:
2015-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-07-15', 'releaseDate': '2016-06-06'}], 'estimatedResultsFirstSubmitDate': '2016-06-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of block', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Duration of block is calculated from time of first pain medication minus time of caudal placement. Caudal placement occurs before pain medication is administered.'}], 'secondaryOutcomes': [{'measure': 'Number of children between the groups who received pain medication in the PACU', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'Number of children between the groups who received pain medication after hospital discharge', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'number of children group between the groups who required pain medication in first 24 h after surgery', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'Awakening time', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Awakening time is calculated from the end of anesthesia to time to reach Steward Score of 6. Patients who are awake, coughing/crying, and have purposeful movements are assigned a Steward Score of 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Analgesia', 'caudal analgesia', 'ropivacaine', 'clonidine', 'dexamethasone'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.', 'detailedDescription': 'The local anesthetic, which is currently used for caudal analgesia, is called ropivacaine. It works well and is safe in infants and children. Doctors commonly add small amounts of other medication to ropivacaine to prolong the duration of pain relief provided by a single injection of caudal analgesia.\n\nIn this study, the length of duration of pain relief the child receives from caudal analgesia will be examined when different medications are added to ropivacaine. Specifically, dexamethasone, clonidine, or saline (salt water) will be added to ropivicaine and the length of time it takes before the child needs more pain medication will be determined.\n\nClonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relieving effect of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive.\n\nDexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject will receive presurgical caudal block\n* American Society of Anesthesiologists (ASA) 1 or 2\n* Day surgery unit\n* weight 30 kg or less\n\nExclusion Criteria:\n\n* Neuromuscular disease\n* Back problem\n* Caudal area skin infection\n* Mental retardation\n* Developmental delay\n* Bleeding disorder'}, 'identificationModule': {'nctId': 'NCT02773602', 'briefTitle': 'Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effect of Dexamethasone or Clonidine When Given as Adjuncts to Ropivacaine for Caudal Analgesia on Duration of Analgesia Compared to Placebo in Children', 'orgStudyIdInfo': {'id': 'HSC-MS-11-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine The patient will receive Ropivacaine plus 200 μgm/kg of dexamethasone in 1 ml saline', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clonidine', 'description': 'Clonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relief of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive.\n\nThe patient will receive Ropivacaine plus 2 μg/kg of clonidine in 1 ml saline.', 'interventionNames': ['Drug: Clonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'The patient only will receive Ropivacaine', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '200 μgm/kg of dexamethasone in 1 ml saline', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Clonidine', 'type': 'DRUG', 'description': '2 μg/kg of clonidine in 1 ml saline', 'armGroupLabels': ['Clonidine']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'EMAD M SORIAL, (M.B; B.CH)', 'role': 'CONTACT', 'email': 'EMAD.M.SORIAL@UTH.TMC.EDU', 'phone': '713-550-6186'}, {'name': 'Samia N Khalil, (M.B; B.CH)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Emad m. Sorial, (M.B; B.CH).', 'role': 'CONTACT', 'email': 'emad.m.sorial@uth.tmc.edu', 'phone': '+1-713-500-6186'}], 'overallOfficials': [{'name': 'Samia N Khalil, (M.B; B.CH)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of pediatric Anesthesia', 'investigatorFullName': 'Samia Khalil', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-06-06', 'type': 'RELEASE'}, {'date': '2016-07-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Samia Khalil, Professor of pediatric Anesthesia, The University of Texas Health Science Center, Houston'}}}}