Using Ketorolac to improve recovery after palatoplasty for cleft lip and palate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.