Ketorolac in Palatoplasty

Cleft Lip and Palate Clinical Trial

Official title:

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771156
• Other study ID #: HSC-MS-21-0044
• Status: Recruiting
• Phase: Phase 4
• Start date: September 17, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Matthew R Greives, MD,MS,FACS
• Phone: (713) 500-7275
• Email: Matthew.R.Greives[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to first oral intake		within 24 hours post surgery
Secondary	Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room		24 hours and 48 hours after surgery
Secondary	Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)		7 days post surgery
Secondary	Number of participants who need narcotic prescription at discharge		at discharge(24-48 hours post surgery)
Secondary	Renal function measured in mL/kg of urine output		from arrival to PACU to discharge (24-48 hours post surgery)
Secondary	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