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Ketorolac in Palatoplasty

Primary Purpose

Cleft Lip and Palate

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketorolac

Placebo

About this trial

This is an interventional treatment trial for Cleft Lip and Palate

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group (Ketorolac)

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Volume of oral intake

This will be measured in mL's of fluids

Secondary Outcome Measures

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

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

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

Pain as assessed by the Faces scale

Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome

Time to first oral intake

Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room

Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)

Number of participants who need narcotic prescription at discharge

Renal function measured in mL/kg of urine output

Number of participants with post operative complications

post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever

Full Information

NCT ID

NCT04771156

First Posted

February 22, 2021

Last Updated

June 2, 2022

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04771156

Brief Title

Ketorolac in Palatoplasty

Official Title

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cleft Lip and Palate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group (Ketorolac)

Arm Type

Experimental

Arm Title

Control Group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ketorolac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Information:

Title

Volume of oral intake

Description

This will be measured in mL's of fluids

Time Frame

from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery

Secondary Outcome Measure Information:

Title

Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

Description

This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

Time Frame

immediately upon arrival at PACU

Title

Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

Description

This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

Time Frame

24 hours post surgery

Title

Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

Description

This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

Time Frame

48 hours post surgery

Title

Pain as assessed by the Faces scale

Description

Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome

Time Frame

7 days post discharge

Title

Time to first oral intake

Time Frame

within 24 hours post surgery

Title

Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room

Time Frame

24 hours and 48 hours after surgery

Title

Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)

Time Frame

7 days post surgery

Title

Number of participants who need narcotic prescription at discharge

Time Frame

at discharge(24-48 hours post surgery)

Title

Renal function measured in mL/kg of urine output

Time Frame

from arrival to PACU to discharge (24-48 hours post surgery)

Title

Number of participants with post operative complications

Description

post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever

Time Frame

30 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew R Greives, MD,MS,FACS

Phone

(713) 500-7275

Matthew.R.Greives@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Alfredo Cepeda Jr., MD

Phone

(713) 500-7216

Alfredo.Cepeda@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew R Grieves, MD,MS,FACS

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew R Greives, MD,MS,FACS

Phone

713-500-7275

Matthew.R.Greives@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Alfredo Cepeda Jr., MD

Phone

(713) 500-7216

Alfredo.Cepeda@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ketorolac in Palatoplasty

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