Using Ketorolac to improve recovery after palatoplasty for cleft lip and palate
Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
This study tests if giving Ketorolac along with regular pain relief can help patients recover better and eat more easily after surgery for cleft lip and palate.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04771156 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravenous Ketorolac as an addition to standard multi-modal pain management in patients undergoing palatoplasty for cleft lip and palate. The goal is to determine if this intervention can enhance oral intake following surgery compared to usual care alone. Participants will be randomly assigned to receive either Ketorolac or a placebo, allowing for a controlled comparison of outcomes. The study focuses on patients with both complete and incomplete cleft palates, with or without associated cleft lip.
Who should consider this trial
Good fit: Ideal candidates are patients with cleft palate, either complete or incomplete, who are scheduled for palatoplasty.
Not a fit: Patients with syndromic cleft palate, previous palatoplasty, or significant medical history that contraindicates NSAID use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and oral intake for patients undergoing palatoplasty.
How similar studies have performed: Other studies have explored the use of NSAIDs in post-operative pain management, showing promising results, but this specific application of Ketorolac in palatoplasty is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Matthew R Grieves, MD,MS,FACS — The University of Texas Health Science Center, Houston
- Study coordinator: Matthew R Greives, MD,MS,FACS
- Email: Matthew.R.Greives@uth.tmc.edu
- Phone: (713) 500-7275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.