Double-Blind Randomized Placebo-Controlled Trial of Single-Dose Intravenous Acetaminophen for Pain Associated With Adenotonsillectomy in Pediatric Patients With Sleep-Disordered Breathing.

OBJECTIVES: Adequate pain control is an important component in the postoperative outcome for pediatric adenotonsillectomy patients with sleep-disordered breathing (SDB). Intravenous acetaminophen appears to be a favorable analgesic adjunct owing to its predictable pharmacokinetics and opioid-sparing effects; however, its role in pediatric adenotonsillectomy pain management remains unclear.
METHODS: In this prospective, randomized, double-blinded, controlled study, subjects with the diagnosis of SDB, aged 2 to 8 years, who required extended postoperative admission, received intravenous acetaminophen (15 mg/kg) or saline placebo intraoperatively in addition to morphine (0.1 mg/kg) for postoperative surgical analgesia. Pain scores in the postanesthesia care unit (PACU) using the FLACC (Faces, Leg, Activity, Cry, Consolability) score were used to determine the need for supplemental analgesic agents in the PACU. The PACU time and time to the first request for pain medication on the inpatient ward were also measured.
RESULTS: A total of 239 patients were included in the final data analysis (118 in the intravenous acetaminophen group and 121 in the saline placebo group). The 2 groups did not differ in the proportion of patients reaching FLACC scores = 4 in the PACU (p = 0.223); mean FLACC scores in the PACU (p = 0.336); mean PACU time (p = 0.883); or time to requesting pain medication on the inpatient ward (p = 0.640).
CONCLUSIONS: A single intraoperative dose of intravenous acetaminophen did not alter the postoperative course of pediatric patients with SDB following adenotonsillectomy.

RCT Entities:   Population Interventions Outcomes