Recruiting

Ketorolac

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04771156

Conditions

Cleft Lip and Palate

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Placebo

Study Details

Brief 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

Conditions

Cleft Lip and Palate

Study ID

NCT04771156

Start date

Sep 17, 2021

Status verified date

Feb, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental group (Ketorolac)

placebo comparator: Control Group

Interventions

Ketorolac

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

Placebo

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.

Primary outcome measure

  • Volume of oral intake [ Time Frame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery ]

Central Contacts and Locations

Central contacts

Matthew R Greives, MD,MS,FACS

(713) 500-7275Matthew.R.Greives@uth.tmc.edu

Tien Do, DO

Tien.Do@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Matthew R Greives, MD,MS,FACS

713-500-7275Matthew.R.Greives@uth.tmc.edu

Tien Do, DO

Tien.Do@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-19.