Comparing efficacy and tolerability of ibuprofen and paracetamol in fever.

Abstract

The purpose of this study was to compare antipyretic activity and evaluate tolerability of ibuprofen and paracetamol suspension in the treatment of febrile children. It was designed as a double blind, parallel group, multiple dose study comparing ibuprofen (20 mg/kg/24 hours) with paracetamol (50 mg/kg/24 hours) given at six hourly intervals for a maximum of 12 doses. Children on paediatric wards between the ages of 0-2 and 12 years, with fever as defined by an axillary temperature ¢ 37 5°C, were included. The main outcome measures were: change in axillary temperature; palatability of medication; changes in irritability and clinical condition; overall efficacy at the end of treatment; and number and nature of adverse events.The mean temperature change from baseline at four hours was -1-8°C and -1 60C in ibuprofen and paracetamol groups respectively. In both groups: median palatability score was 'no reaction'; median irritability score at end point was 'not irritable'; median score for change in clinical condition was 'improved'; and median score for overall efficacy was 'good effect'. The proportion of patients experiencing adverse events was similar in both groups, the majority of events having doubtful or no relationship to therapy and being mild in severity.In conclusion, ibuprofen suspension was as effective and well tolerated as paracetamol in treatment of fever in young children.

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial

“…In the second study, reduction in temperature and improvement in discomfort levels were more or less equal in the two groups. 60 Among the combined treatment trials, we found no study investigating whether there is a relationship between a child's temperature and his or her level of discomfort.…”

“…Among the studies comparing antipyretic monotherapies, we found two 59,60 in which both temperature and fever-associated symptoms were measured. In the first, 59 although no direct association between temperature and discomfort was described, at 6 hours temperature had fallen to a greater extent and discomfort levels had improved more in the ibuprofen group than in the paracetamol group.…”

“…In another trial randomising 74 children to paracetamol 50 mg/ kg/24 hours and 76 to ibuprofen 20 mg/kg/24 hours, no adverse events were thought to be even possibly related to paracetamol, whereas three adverse events (one each of urticarial rash, respiratory distress and diarrhoea) were thought to be 'possibly' related to ibuprofen. 60 In another trial of 64 children randomised to receive paracetamol 15 mg/kg or ibuprofen 10 mg/kg, three children in the paracetamol group withdrew after two doses due to hypothermia (exact definition not given) and one ibuprofen-treated child withdrew because of nausea, vomiting and abdominal pain. Additional mild adverse reactions to paracetamol included abdominal pain (3) and agitation (3), and to ibuprofen sweating (8) and 'gastrointestinal complaints' (7).…”

Acetaminophen and ibuprofen

“…Doses of 10 mg/kg of both drugs were compared in three large studies: one found no difference (7), and in the others, ibuprofen was found to be more effective than APAP (9,11). APAP 12.5 mg/kg has been compared with ibuprofen 5 to 10 mg/kg in three studies (13,14,16). One showed that 8 mg/kg ibuprofen caused greater temperature reduction (13,14), and two demonstrated that ibuprofen 5 mg/kg was not different from APAP 12.5 mg/kg (13,16).…”

“…APAP 12.5 mg/kg has been compared with ibuprofen 5 to 10 mg/kg in three studies (13,14,16). One showed that 8 mg/kg ibuprofen caused greater temperature reduction (13,14), and two demonstrated that ibuprofen 5 mg/kg was not different from APAP 12.5 mg/kg (13,16). A 1976 study showed that ibuprofen 6 mg/kg was as effective as APAP 12.5 mg/kg (15).…”