Efficacy and Tolerability of Intravenous Paracetamol Compared to Oral Paracetamol for the Treatment of Childhood Fever

Introduction: Paracetamol is widely used as antipiretic in children and has complete rute. The use of enteral rute is limited because of high variability of bioavailability. Intravenous paracetamol commonly used as accessible analgetic in adult. There are limited data about efficacy and tolerability intravenous paracetamol compares to oral paracetamol as antipiretic in children. The aim of the study is to analyse efficacy and tolerability intravenous paracetamol compared to oral paracetamol for treating fever in children. Methods: A randomized, controlled, and open labelled clinical trial was conducted at pediatric ward Soetomo hospital Surabaya. Eligible patients received either intravenous paracetamol or oral paracetamol 10 mg/kgBW and were examined for temperature at 15, 30, 45, 60, 120, 180 and 240 minutes. Tolerability evaluations included adverse event (AE), physical exam and laboratory assessments. Results: Of 104 patients, 52 received intravenous paracetamol intravena and 52 received oral paracetamol. Mean temperature intravenous group were lower than oral groups, with higher degree of decrease. The difference were achieved at 30, 45, and 60 minutes with p=0.005, 0.002, and 0.006 respectively. Maximum decrease from baseline were achieved at 120-minute for intravenous grup and 180-minute for oral groups. Normal temperature achievement were higher in intravenous group than oral. The adverse event were comparable between the intravenous and oral groups. Conclusion: Intravenous paracetamol is more effective and as safe as oral paracetamol in reducing fever in children.