RecruitingPhase 4NCT04771156

Ketorolac in Palatoplasty

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

74 participants

Start Date

Sep 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 Months

Inclusion Criteria1

  • Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral

Exclusion Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04771156


Related Trials