Ketorolac in Palatoplasty
1 other identifier
interventional
74
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 19, 2026
February 1, 2026
5.5 years
February 22, 2021
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
immediately upon arrival at PACU
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
24 hours post surgery
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
48 hours post surgery
Pain as assessed by the Faces scale
7 days post discharge
Time to first oral intake
within 24 hours post surgery
- +5 more secondary outcomes
Study Arms (2)
Experimental group (Ketorolac)
EXPERIMENTALControl Group
PLACEBO COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew R Grieves, MD,MS,FACS
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
September 17, 2021
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share