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Search / Trial NCT04771156

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Ketorolac on patients undergoing a surgical procedure known as palatoplasty, which is often needed for children with cleft lip and palate. The researchers want to find out if adding Ketorolac to the usual pain management methods can help patients eat and drink better after their surgery. The trial is currently looking for participants who are 18 years or older and have a cleft palate, whether it’s complete or incomplete, and with or without a cleft lip.

To participate, patients must not have certain health issues, such as a history of serious heart problems or stomach ulcers, and cannot have had previous palate surgery. If eligible, participants will receive the usual care for pain, along with the Ketorolac, and their recovery, particularly how well they can eat and drink after surgery, will be monitored. This study aims to improve recovery experiences for those with cleft lip and palate, making it an important step in enhancing post-surgery care.

Gender

ALL

Eligibility 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

About The University Of Texas Health Science Center, Houston

The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Matthew R Grieves, MD,MS,FACS

Principal Investigator

The University of Texas Health Science Center, Houston

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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