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Ketorolac for Cleft Lip and Palate

Phase 4

Recruiting

Led By Matthew R Grieves, MD,MS,FACS

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours and 48 hours after surgery

Awards & highlights

Study Summary

This trial will test whether adding the drug ketorolac to standard post-operative care can improve a patient's ability to eat afterwards.

Who is the study for?

This trial is for patients with cleft palate, with or without a cleft lip, who haven't had palatoplasty before. It's not for those with kidney issues, bleeding disorders that make NSAIDs risky, GI complications like ulcers or bleeds, syndromic cleft palate conditions, serious heart defects uncorrected by surgery, or if they rely on feeding tubes.Check my eligibility

What is being tested?

The study is testing whether adding IV Ketorolac to the usual pain management after palatoplasty helps improve oral intake post-surgery compared to standard care alone. Participants will either receive Ketorolac or a placebo.See study design

What are the potential side effects?

Ketorolac may cause side effects such as stomach pain and ulcers, bleeding problems (like nosebleeds), headaches, dizziness and can affect kidney function. Not everyone will experience these side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours and 48 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours and 48 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours and 48 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Volume of oral intake

Secondary outcome measures

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

Number of participants who need narcotic prescription at discharge

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

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental group (Ketorolac)Experimental Treatment1 Intervention

Group II: Control GroupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac

2014

Completed Phase 4

~1760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,886 Total Patients Enrolled

3 Trials studying Cleft Lip and Palate

51 Patients Enrolled for Cleft Lip and Palate

Matthew R Grieves, MD,MS,FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Ketorolac Clinical Trial Eligibility Overview. Trial Name: NCT04771156 — Phase 4

Cleft Lip and Palate Research Study Groups: Control Group, Experimental group (Ketorolac)

Cleft Lip and Palate Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT04771156 — Phase 4

Ketorolac 2023 Treatment Timeline for Medical Study. Trial Name: NCT04771156 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies remaining for this clinical experiment?

"Affirmative. The details on clinicaltrials.gov demonstrate that this experiment, which was initially posted on September 17th 2021, is presently recruiting participants. Approximately 74 individuals have to be enrolled from 1 clinic sites."

Answered by AI

Could you please enumerate the prior investigations involving Ketorolac?

"At the moment, 38 trials related to Ketorolac have been launched. 8 of those are in Phase 3 and 57 different locations around Los Angeles are participating."

Answered by AI

What conditions is Ketorolac commonly employed to address?

"Ketorolac is a powerful pharmaceutical tool for managing ocular discomfort, nerve blockages and itching."

Answered by AI

Does Ketorolac present any undue risks for patients?

"There is ample evidence that Ketorolac is safe, and so the Power team assigned a score of 3 to assess its safety. This Phase 4 trial marks this medication as an approved treatment choice."

Answered by AI

How many individuals will be included in this medical experiment?

"Correct. Per the information located on clinicaltrials.gov, this research is presently looking for participants. The study was published on September 17th 2021 and has been updated most recently on June 2nd 2022. 74 individuals must be found across 1 medical centre to take part in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketorolac in Palatoplasty

Matthew Greives 2021. "Ketorolac in Palatoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04771156.