An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital

Abstract

Background: Tramadol is widely used worldwide to treat moderate to severe pain in children. There are growing concerns regarding the safety of tramadol use in children in recent years when the US FDA (Food and Drug Administration) issued a safety announcement that restricts tramadol use in children less than 18 years old to treat pain after tonsillectomy and adenoidectomy. After this FDA announcement, our hospital stopped using tramadol in children less than 18 years old. Objective: we planned to audit our experience in the use of intravenous tramadol in children for postoperative pain management in recovery area. Methods: Institutional Review Board (IRB) waived written informed consent. After getting the IRB approval, we reviewed the anesthesia records of 16130 patients between the years 2015 and 2017. We looked for patients who received tramadol postoperatively in PACU (post-anesthesia care unit). We looked for postoperative complications or adverse events in the form of apnea, hypopnea, bradycardia, postoperative nausea and vomiting, prolonged stay in recovery, unplanned admission, or admission after discharge within 48 hours. Statistical analysis was done using Wilcoxon scores for variables, Wilcoxon 2 sample test, calculated odd's Ratio and 95% confidence interval and P-values where P values less than 0.05 were considered significant. Results: Seven patients desaturated out of 430 patients. They needed oxygen support in the form of simple facemask or nasal cannula but no one needed positive pressure ventilation. No one developed apnea or bradycardia or needed naloxone administration. There was no readmission after discharge from the hospital. There was only one unplanned admission due to a surgical cause. The average duration of stay in the PACU was 86 minutes. Almost all (418) patients stayed more than 45 min (97.2%). Ninety-two patients had PONV (postoperative nausea and vomiting) (21.39%). There was positive correlation between PONV and total tramadol dose, while a comparison of the Pearson correlations showed that duration of the procedure was the best predictor of PACU duration with an R-value of 0.188 which was highly significant at the P<0.0001. Conclusion: Tramadol does not cause respiratory depression in children, especially when given in a controlled and monitored setup in the operating room and recovery area however Still, Tramadol needs to be studied more in pediatric anesthesia and analgesia and more comparative data is required to determine the safety of available opioids in this setting.