Intravenous Acetaminophen and Ketorolac for Pain Management in Children on Mechanical Ventilation with Acute Respiratory Failure

What this Trial Is About

Researchers are studying pain management in children aged 2 months to 17 years 6 months who require mechanical ventilation for acute respiratory failure. The trial aims to evaluate whether adding intravenous acetaminophen andor ketorolac, which are non-opioid pain medications, can improve pain control and reduce the need for opioids. This study is a randomized, double-blind, placebo-controlled trial to find better pain relief options for critically ill children. Participants will be randomly assigned to one of four groups receiving different combinations of intravenous acetaminophen, ketorolac, or placebo every 6 hours for up to 5 days. All participants will continue to receive opioids as per standard care. The four study groups include acetaminophen plus placebo, ketorolac plus placebo, both acetaminophen and ketorolac, or placebo alone. The study uses a factorial design to assess the effects of these medications individually and combined. During the trial, children will be closely monitored for pain episodes and medication use during the first 5 days of mechanical ventilation or until they are extubated. Researchers will track opioid and benzodiazepine exposure along with pain control. The study includes assessments of pain levels and medication use to understand how the treatments affect these outcomes. Safety and effectiveness will be evaluated under medical supervision throughout the study duration.

Optimizing Pain Treatment in Children On Mechanical Ventilation