A Comparison of Postoperative Tramadol versus Acetaminophen with Codeine in Children Undergoing Tonsillectomy

Abstract

Objectives: 1) Evaluate the effectiveness of tramadol compared to codeine/acetaminophen for post-tonsillectomy pain management. 2) Describe the safety and side effects of tramadol compared to codeine/acetaminophen during the post-tonsillectomy recovery period. Methods: Prospective, double-blinded, randomized controlled clinical trial of children ages 4-15 who underwent routine tonsillectomy (with or without adenoidectomy) surgery at Children’s Hospitals and Clinics of Minnesota in 2011 and 2012. Children were randomized to receive scheduled—followed by PRN—dosing of either tramadol or codeine/acetaminophen. Primary outcomes were assessed during a 10-day postoperative follow-up period with parent diaries and chart review. Diaries captured the following domains: physical recovery; pain (multiple pain scales); sleep; side effects; need for medical attention; and global satisfaction with treatment. Results: The final sample of 74 children was mostly white (92%), female (65%), and 6 years of age (range 4-14). Most parents completed diaries for ≥ 4 days (92%). There were no significant differences between groups in terms of medication efficacy or overall experience with side effects. Groups did not differ in terms of days with a mean pain score >4 ( P = 0.85) (tramadol = 1 day; codeine = 1.5 days). Conclusions: There were no differences between groups in terms of postoperative medication efficacy or safety in this small trial. Due to codeine’s declining acceptability for use in children and risks associated with its efficacy and safety, tramadol should be considered as a first line prescription for children undergoing this common procedure. Further evaluations of oral pain medications for post-tonsillectomy care should be conducted.