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.