Status:
RECRUITING
Ketorolac in Palatoplasty
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Cleft Lip and Palate
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
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
Eligibility Criteria
Inclusion
- Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
Exclusion
- Syndromic Cleft Palate patients
- 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
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04771156
Start Date
September 17 2021
End Date
January 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030