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

  • Nour C
  • Ratsiu J
  • Singh N
 et al. 
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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 ; 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 ) than control patients (454.2; 384.3-524.2 ; P < 0.002). Opioid requirement in oral patients (376.5; 304.1-448.9 ) 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.

Author-supplied keywords

  • Acetaminophen/*therapeutic use
  • Analgesics, Non-Narcotic/*therapeutic use
  • Child, Preschool
  • Cleft Palate/*surgery
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Pain Measurement/drug effects
  • Pain, Postoperative/*drug therapy
  • Postoperative Complications/epidemiology
  • Prospective Studies
  • Treatment Outcome
  • acetaminophen
  • cleft palate
  • congenital abnormalities and syndromes
  • pain PACU
  • pain miscellaneous

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  • C Nour

  • J Ratsiu

  • N Singh

  • L Mason

  • A Ray

  • M Martin

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