Objective: To investigate whether paracetamol administration (i) increases the overall duration of fever; and (ii) is effective and safe, in symptomatic treatment of febrile children.
Design: Randomized double blind placebo controlled trial.
Methods: The trial was conducted at a tertiary care setting. 210 febrile children (6 months - 6 years) with uncomplicated respiratory tract infection received oral paracetamol (15 mg/kg) or placebo, if axillary temperature was 37.6C. Outcome measures included fever clearance time, rate of fall of temperature, percent reduction of temperature, proportion of afebrile children, symptomatic improvement (based on categorical improvement in activity, alertness mood, comfort, appetite and fluid intake) and clinical and biochemical adverse effects.
Results: Fever clearance time [median (SE, 95% CI)] was comparable between the two groups [paracetamol: 32 (2, 22-37) h; placebo: 36 (1, 33-39) h; P = 0.23]. Paracetamol resulted in significantly higher rate of fall of temperature (paracetamol: 0.33 +/-; 0.16 degrees C/h; placebo 0.07 +/- 0.13 degrees C/h: P <0.001), and percentage reduction of temperature (paracetamol: 85.4 +/- 22.4; placebo 45.5 +/- 34.1; mean difference 39.9; 95% CI 31.9-47.9; P<0.001) during first four hours after drug administration. Proportion of afebrile children after 4 hours (paracetamol: 46.6%; placebo: 12.1%; P <0.001) and symptomatic improvement at 6 hours were significantly higher (P<0.001) after administration of paracetamol as compared to placebo. No serious clinical or biochemical adverse drug effects were observed.
Conclusions: Paracetamol achieves effective antipyresis and provides early symptomatic improvement in children with febrile illness without prolongation of fever duration or excessive adverse effects.