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New treatment option for Cleft Lip and Palate
Official title Ketorolac in Palatoplasty
ClinicalTrials.gov ID: NCT04771156
What this study is testing
What is Ketorolac?
Ketorolac is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cleft lip and palate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- -Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
You likely can't join 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)
See the full eligibility criteria
- -Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.