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Compares treatment options for Congenital Heart Disease in Children
Official title Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
ClinicalTrials.gov ID: NCT04040452
What this study is testing
What is Continuous ketorolac?
Continuous ketorolac is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for congenital heart disease in children.
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 proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 59
You may be able to join if
- All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing
- Initiation of study medication within the first 12-24 hours post-operatively
- The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive...
You likely can't join if
- Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria.
- History of allergy or sensitivity reaction to ketorolac or any NSAID medications.
- Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively
- Orthotopic heart transplantation
- Clinically significant bleeding
- Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 3 months to 59 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, 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.