Bupivacaine infiltration in children for postoperative analgesia after tonsillectomy: A randomised controlled trial.

BACKGROUND: Adenotonsillectomy is a frequently performed procedure in paediatric day-case surgery. Postoperative pain can be significant and standard analgesia protocols are often insufficient. OBJECTIVE: Our primary objective was to investigate if infiltration of the peritonsillar space with bupivacaine would reduce the need for postoperative opioids compared with pre-emptive intravenous tramadol. DESIGN: A double-blind, randomised controlled trial. SETTING: Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from January 2012 to September 2016. PATIENTS: Two hundred children, between 4 and 10 years old, undergoing elective adenotonsillectomy were included in the study. INTERVENTION: Children were randomly allocated to receive either a bolus of 3 mg kg intravenous tramadol or infiltration of the tonsillar lodge with 5-ml bupivacaine 0.25%. Reasons for exclusion were American Society of Anesthesiologists classification greater than 2, allergies to the investigated products, psychomotor retardation, bleeding disorders and lack of proficiency in Flemish. MAIN OUTCOME MEASURES: The primary endpoint was the number of children in need of piritramide postoperatively. Secondary outcomes included the cumulative dose of postoperative piritramide, pain scores and the incidence of postoperative nausea and vomiting during the first 24 postoperative hours, time to discharge and adverse effects. RESULTS: The proportion of children in need of postoperative piritramide was significantly lower in the tramadol group than in children with peritonsillar infiltration (57 vs. 81%, P < 0.001). When in need of postoperative piritramide, the tramadol-group required a significantly lower dose (median [IQR] 0.7 [0.6 to 1] vs. 1 [0.6 to 1.5] mg, P < 0.007) and had lower pain scores during the first 60 min after surgery. There were no statistically significant differences in postoperative nausea and vomiting incidence, need for antiemetics or complications. CONCLUSION: Compared with peritonsillar infiltration, preemptive intravenous tramadol decreases the need for postoperative opioids after tonsillectomy in children without increasing the incidence of side effects. TRIAL REGISTRATION: EudraCT 2011-005467-25.