MULTI-CENTER STUDY COMPARING EFFICACY AND TOLERABILITY OF CHILDREN��S
MOTRIN® VS DIPYRONE INJECTABLE IN FEBRILE CHILDREN
SHEN
Kunling
Beijing
Children Hospital
Shanghai
Second Medical University affiliated Xinhua Hospital
Chongqing Medical
University affiliated Children Hospital
Guangzhou
Children Hospital
Nanjing Children Hospital
Objective: The aim of the study is to compare the efficacy and
tolerability of a single dose of Children��s Motrin®
Suspension Liquid or Suspension Drop Vs Dipyrone Injectable used as
antipyretics in febrile children.
Methods: This was a double blind,
single dose, multi-center, parallel, randomized study. All eligible
subjects were randomized to Dipyrone or Ibuprofen treated group. The dosage ranged from 6.3~9.4mg/kg
for each group. For efficacy analysis,
the onset of action, the duration of action, the difference of temperature
from baseline, the analgesic effect and the investigator��s overall
impression of each treatment were analyzed. For tolerability evaluation,
all adverse experience during the 8 hours period of study was analyzed. All
statistical tests were two-sided at significance level of 0.05.
Results: The demographic data of the Motrin group and the Dipyrone group
were comparable. As comparing the efficacy data, the overall antipyretic
effect of Motrin group was 99.3% which was superior to 88.6% of Dipyrone
group, p<0.05. The result showed that time at onset of antipyretic
effect, which was defined as the earliest time that the temperature was³1.0 degree centigrade below baseline, is earlier in Motrin group(1.16��0.10h) than in Dipyrone group(1.68��0.15h), p<0.05. In Motrin group duration of antipyretic effect
was almost up to 8 hours which was longer than in Dipyrone group, p<0.05.
The maximum temperature decline (2.30��0.65��C) was larger in Motrin group than in Dipyrone group(1.85��0.82��C), p<0.05. Accordingly, the maximum
percentage of decline was larger in Motrin group(88.3��26.3%) than in Dipyrone group(69.7��30.2%), p<0.05. The overall appraisal by investigator was
significantly better in Motrin group than that in Dipyrone group, p<0.05.
Each group had good effect on pain relief after medication, p<0.05. No
adverse experience occurred.
Conclusions: Children��s
Motrin® suspension liquid and drop were highly effective and
safe for children��s fever, which in turn became the better choice in the
clinical practice in pediatric emergency unit.