NCT04040452 Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
| NCT ID | NCT04040452 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Phoenix Children's Hospital |
| Condition | Congenital Heart Disease in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 166 participants in total. It began in 2021-03-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Initiation of study medication within the first 12-24 hours post-operatively 3. The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control Exclusion Criteria: 1. Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria. 2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications. 3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively 4. Orthotopic heart transplantation 5. Clinically significant bleeding 6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity
Contact & Investigator
Kevin Engelhardt, MD
PRINCIPAL INVESTIGATOR
Heart Center
Frequently Asked Questions
Who can join the NCT04040452 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 59 Months, studying Congenital Heart Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04040452 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04040452 currently recruiting?
Yes, NCT04040452 is actively recruiting participants. Contact the research team at kengelhardt@phoenixchildrens.com for enrollment information.
Where is the NCT04040452 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT04040452 clinical trial?
NCT04040452 is sponsored by Phoenix Children's Hospital. The principal investigator is Kevin Engelhardt, MD at Heart Center. The trial plans to enroll 166 participants.