Plain-English translation of NCT04040452 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing whether ketorolac — a non-opioid pain medication — works better when given continuously (like a steady flow) rather than in separate doses after heart surgery in young children. The goal is to help children manage pain while reducing their need for opioid medications, which can cause serious side effects and complications during recovery.
Doctors want to find safer ways to control pain after heart surgery in young children. Opioid medications, while effective, can cause problems like unstable heart function, dependency, and long-term effects on brain development. Research in adults suggests this medication might be safer and more effective, but we need to know if it works the same way in children.
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If your child is enrolled, they will receive either the new continuous pain medication or a placebo (dummy medication that looks the same) for 48 hours after heart surgery. Both groups will also receive regular doses of a salt solution every 6 hours. The hospital team will monitor your child closely and manage pain as needed during this time.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
United States
Post-approval monitoring
Sponsor
Phoenix Children's Hospital
Enrollment target
~166 participants
Started
March 2021
Primary completion
June 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
3 Months – 59 Months
Last updated on clinicaltrials.gov in April 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Kevin Engelhardt, MD
Heart Center
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.