Ketorolac in Palatoplasty

Phase 4

Recruiting

• Conditions: Cleft Lip and Palate
• Interventions: Drug: Placebo; Drug: Ketorolac

• Registration Number: NCT04771156
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Start: 2021-09-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
Experimental group (Ketorolac)	Ketorolac	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain as assessed by the Faces scale	7 days post discharge	Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome
Time to first oral intake	within 24 hours post surgery
Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)	7 days 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	30 days post surgery	post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale	48 hours post surgery	This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome
Number of participants who need narcotic prescription at discharge	at discharge(24-48 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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States