Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients

What this Trial Is About

Researchers are evaluating whether a continuous infusion of ketorolac reduces the need for opioid medications for pain control after surgery in children with congenital heart disease in the pediatric cardiovascular intensive care unit. This study is a randomized, double-blind, placebo-controlled trial aiming to compare continuous ketorolac infusion with intermittent ketorolac dosing. The goal is to see if continuous infusion can lower opioid use and potentially reduce opioid-related complications in this sensitive patient group. Participants are randomly assigned to one of two groups. The treatment group receives a continuous intravenous infusion of ketorolac at 0.08 mg/kg/hour (up to 5 mg/hour for patients 60 kg or more) for 48 hours plus intermittent placebo doses every 6 hours. The control group receives continuous placebo infusion with intermittent ketorolac doses of 0.5 mg/kg every 6 hours (up to 30 mg per dose) for 48 hours. No additional NSAIDs except aspirin are allowed during the study period. Participants will be closely monitored for pain control, opioid use, and safety outcomes during the first 72-96 hours after cardiac surgery. Researchers will measure total fentanyl doses, pain scores, sedative needs, kidney injury rates, and bleeding events. The study includes assessments of opioid use within the first 96 hours post-operation, and participants' health status will be tracked throughout the study period, which began in 2021 and continues until 2026.

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery