Project 467217

1-2% of infants and toddlers need surgery annually. Managing their pain after surgery is challenging. Opioids are commonly used but have many side effects. Due to these side effects, doctors use multiple types of medications for postoperative pain to help reduce opioid use. Studies show that intravenous acetaminophen, a non-opioid medication, reduces pain and adverse events after surgery in adults and older children. However, in infants, there is little data on this topic and for premature infants there is none. This gap has led to our research question: Does adding intravenous acetaminophen to term and preterm infants opioid-based postoperative pain regime reduce pain, opioid use, and side effects. To answer this question, a blinded, randomized pilot study enrolling 60 patients will be conducted to estimate the feasibility and cost of running a large multicenter trial. Patients will be randomly assigned to receive a standard postoperative fentanyl infusion and either intravenous acetaminophen at weight and age-appropriate doses and intervals or a saline placebo. Patients will be followed for seven days postoperatively. Primarily the feasibility and cost of running a multicenter trial will be evaluated. Secondarily, clinical outcomes, including pain scores, opioid consumption, complications, and length of stay, will be evaluated. This trial will allow for a thorough largescale randomized control trial to be run to produce high-quality, practice-changing evidence. It will be the first study of its kind to include premature infants and will have the longest follow-up period of a trial on this topic. This trial will also begin to fill the literature gap and provide clinicians with new evidence-based strategies to control pain and reduce opioids in this unique population.