Comparing continuous and intermittent ketorolac for pain control in children after heart surgery
Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients
This study is testing if giving children a steady drip of ketorolac for pain after heart surgery works better than giving it in doses, to see if it helps reduce the need for stronger pain medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 3 Months to 59 Months |
| Sex | All |
| Sponsor | Phoenix Children's Hospital Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT04040452 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized, double-blind, placebo-controlled trial aimed at evaluating the effectiveness of continuous versus intermittent ketorolac for postoperative pain management in pediatric patients undergoing cardiovascular surgery. The goal is to determine if continuous infusion of ketorolac can reduce the need for opioid medications compared to the standard intermittent dosing. Given the risks associated with opioid use in children, this research seeks to provide a safer alternative for pain control in the pediatric cardiovascular intensive care unit (CVICU). The study will involve patients aged 3 months to 4 years who are admitted postoperatively and will assess pain management outcomes within the first 72 hours after surgery.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 4 years who are post-operative patients in the CVICU and are eligible for ketorolac for pain management.
Not a fit: Patients with acute kidney injury, significant bleeding, or those requiring mechanical circulatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced opioid use in pediatric patients, minimizing the risk of complications associated with opioid therapy.
How similar studies have performed: There is existing evidence in adult literature supporting the use of continuous ketorolac for pain control, but this specific approach in pediatric patients is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Engelhardt, MD — Heart Center
- Study coordinator: Kevin Engelhardt, MD
- Email: kengelhardt@phoenixchildrens.com
- Phone: 6029333366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.