Ketorolac in Palatoplasty

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

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

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Drug: Ketorolac; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthew R Greives, MD,MS,FACS; Phone Number: (713) 500-7275; Email: Matthew.R.Greives@uth.tmc.edu
• Study Contact Backup: Name: Tien Do, DO; Email: Tien.Do@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Matthew R Greives, MD,MS,FACS; Phone Number: 713-500-7275; Email: Matthew.R.Greives@uth.tmc.edu
      • Contact: Tien Do, DO; Email: Tien.Do@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Drug: 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.
Experimental: Experimental group (Ketorolac)	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of oral intake	This will be measured in mL's of fluids	from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale	This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome	immediately upon arrival at PACU
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale	This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome	24 hours post surgery
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale	This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome	48 hours post surgery
Pain as assessed by the Faces scale	Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome	7 days post discharge
Time to first oral intake		within 24 hours post surgery
Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room		24 hours and 48 hours after surgery
Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)		7 days post surgery
Number of participants who need narcotic prescription at discharge		at discharge(24-48 hours post surgery)
Renal function measured in mL/kg of urine output		from arrival to PACU to discharge (24-48 hours post surgery)
Number of participants with post operative complications	post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever	30 days post surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Matthew R Grieves, MD,MS,FACS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Lip; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indomethacin; Indoles; Ketorolac
• Other Study ID Numbers: HSC-MS-21-0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No