Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT04771156
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketorolac in Palatoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of oral intake', 'timeFrame': 'from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery', 'description': "This will be measured in mL's of fluids"}], 'secondaryOutcomes': [{'measure': 'Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale', 'timeFrame': 'immediately upon arrival at PACU', 'description': 'This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome'}, {'measure': 'Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale', 'timeFrame': '24 hours post surgery', 'description': 'This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome'}, {'measure': 'Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale', 'timeFrame': '48 hours post surgery', 'description': 'This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome'}, {'measure': 'Pain as assessed by the Faces scale', 'timeFrame': '7 days post discharge', 'description': 'Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome'}, {'measure': 'Time to first oral intake', 'timeFrame': 'within 24 hours post surgery'}, {'measure': 'Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room', 'timeFrame': '24 hours and 48 hours after surgery'}, {'measure': 'Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)', 'timeFrame': '7 days post surgery'}, {'measure': 'Number of participants who need narcotic prescription at discharge', 'timeFrame': 'at discharge(24-48 hours post surgery)'}, {'measure': 'Renal function measured in mL/kg of urine output', 'timeFrame': 'from arrival to PACU to discharge (24-48 hours post surgery)'}, {'measure': 'Number of participants with post operative complications', 'timeFrame': '30 days post surgery', 'description': 'post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral\n\nExclusion Criteria:\n\n* Syndromic Cleft Palate patients\n* Previous palatoplasty\n* Major unrepaired cardiac malformation\n* History of GI complications (GI Bleed, Gastric Ulceration)\n* History of Renal disorder\n* History of coagulopathy (As contraindication to NSAID use)\n* Feeding tube dependency\n* Patients whose parents refuse to consent to randomization'}, 'identificationModule': {'nctId': 'NCT04771156', 'briefTitle': 'Ketorolac in Palatoplasty', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.', 'orgStudyIdInfo': {'id': 'HSC-MS-21-0044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (Ketorolac)', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'description': 'Ketorolac 0.5mg/kg will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of Ketorolac', 'armGroupLabels': ['Experimental group (Ketorolac)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% Normal Saline will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of normal saline.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew R Greives, MD,MS,FACS', 'role': 'CONTACT', 'email': 'Matthew.R.Greives@uth.tmc.edu', 'phone': '713-500-7275'}, {'name': 'Alfredo Cepeda Jr., MD', 'role': 'CONTACT', 'email': 'Alfredo.Cepeda@uth.tmc.edu', 'phone': '(713) 500-7216'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Matthew R Greives, MD,MS,FACS', 'role': 'CONTACT', 'email': 'Matthew.R.Greives@uth.tmc.edu', 'phone': '(713) 500-7275'}, {'name': 'Alfredo Cepeda Jr., MD', 'role': 'CONTACT', 'email': 'Alfredo.Cepeda@uth.tmc.edu', 'phone': '(713) 500-7216'}], 'overallOfficials': [{'name': 'Matthew R Grieves, MD,MS,FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew Greives', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}