Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
74 participants
INTERVENTIONAL
2021-09-17
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group (Ketorolac)
Ketorolac
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
Control Group
Placebo
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.
Interventions
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Ketorolac
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
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous palatoplasty
* Major unrepaired cardiac malformation
* History of GI complications (GI Bleed, Gastric Ulceration)
* History of Renal disorder
* History of coagulopathy (As contraindication to NSAID use)
* Feeding tube dependency
* Patients whose parents refuse to consent to randomization
6 Months
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Matthew Greives
Associate Professor
Principal Investigators
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Matthew R Grieves, MD,MS,FACS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-21-0044
Identifier Type: -
Identifier Source: org_study_id
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