Analgesic effectiveness of acetaminophen for primary cleft palate repair in young children: a randomized placebo controlled trial

BackgroundClefting of the lip, palate, or both is a common congenital abnormality. Inadequate treatment for pain in children may result from concerns over opioid-related adverse effects. Providing adequate pain control with minimal adverse effects remains challenging in children. ObjectivesTo assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children. MethodsProspective randomized controlled trial in 45 healthy children, ages 5months to 5years, using standardized general anesthesia and lidocaine infiltration of the operative field. Patients were allocated to groups: intravenous acetaminophen/oral placebo (intravenous), oral acetaminophen/intravenous placebo (oral), or intravenous/oral placebo (control). Groups were compared for differences in opioid administration during the 24-h study period (morphine equivalents mu gkg(-1); 95% confidence interval). ResultsIntravenous acetaminophen decreased opioid requirement after surgery (P=0.003). Patients in the intravenous group received less opioid (272.9; 202.9-342.8 mu gkg(-1)) than control patients (454.2; 384.3-524.2 mu gkg(-1); P<0.002). Opioid requirement in oral patients (376.5; 304.1-448.9 mu gkg(-1)) was intermediate and not significantly different from either intravenous (P=0.11) or control (P=0.27). During the ward phase of care, intravenous had better analgesia than control (P=0.002), and both intravenous and oral group patients received less opioid than control (P=0.01). ConclusionIntravenous acetaminophen given to young children undergoing primary cleft palate repair was associated with opioid-sparing effects compared to placebo. The fewer morphine doses during ward stay in both intravenous and oral may be important clinically in some settings.