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

Background:  Clefting 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.

Objectives:  To assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children.

Methods:  Prospective randomized controlled trial in 45 healthy children, ages 5 months to 5 years, 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 µg·kg(-1) ; 95% confidence interval).

Results:  Intravenous acetaminophen decreased opioid requirement after surgery (P = 0.003). Patients in the intravenous group received less opioid (272.9; 202.9-342.8 µg·kg(-1) ) than control patients (454.2; 384.3-524.2 µg·kg(-1) ; P < 0.002). Opioid requirement in oral patients (376.5; 304.1-448.9 µg·kg(-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).

Conclusion:  Intravenous 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.