Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
The University of Texas Health Science Center, Houston
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
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: -Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral Exclusion Criteria: * 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
Interventions
- DrugKetorolac
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
- DrugPlacebo
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.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas