Randomised comparative trial of the efficacy of paracetamol syrup and dispersible tablets for the treatment of fever in children

Abstract

Objective Fever is the most common reason for the presentation of children in the outpatient department. Paracetamol is marketed in different formulations for ease of administration to the paediatric population. These include syrups, dispersible tablets and rectal inserts. Dispersible tablets disintegrate rapidly in liquid and are subsequently taken orally, providing another oral formulation. We determined if there is a difference in the antipyretic efficacy of the syrup and the dispersible formulation of paracetamol, thereby prompting the development of the latter (another oral formulation) for use in children. Methods A randomised, controlled, double-blind intervention of a single dose of both formulations was given to febrile children, and their temperatures were documented twice in 30-minute intervals. Temperature changes were compared statistically. Results The mean temperatures at recruitment were 38.2 ± 0.5°C and 38.3 ± 0.6°C for the dispersible and syrup group, respectively. There was no significant difference between the temperature changes at T2 (30 minutes) and T3 (60 minutes) between the two study arms. However, the temperature was significantly different at T1 (baseline), T2 and T3 within the dispersible and syrup groups. Conclusion The decreasing trend in temperature was similar in both groups. Both preparations produced statistically similar antipyretic effects with no reported adverse drug reaction.