CONCLUSIONS:Tepid sponging plus dipyrone cooled faster during the fi rst 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.KEY WORDS: Fever. Dipyrone. Child. Baths. Antipyretics.
CLINICAL TRIAL REGISTRATION NUMBER:ACTRN12608000083392.
108Sao Paulo Med J. 2008;126(2):107-11.during the previous six hours were excluded, as were children with known liver or renal diseases, gastrointestinal bleeding, known allergy to dipyrone, congenital or acquired immunodeficiency or malignancy. The same room was used for all children and informed consent to participate in the trial was obtained from the parents. This study was approved by the local institutional human rights committee The children were assigned randomly by drawing a numbered envelope to receive oral dipyrone and tepid sponging (sponging group) or dipyrone only (control group). All children were given 20 mg/kg of dipyrone syrup orally at the beginning of the study procedure. The study medication was administered by staff nurses. Children assigned to receive tepid sponging were naked and sponged from head to toe (except the scalp), for 15'. The temperature of the water used ranged from 28 C to 32 C. The ambient temperature throughout the period of the study ranged from 27 C to 30 C. Axillary temperatures were the primary outcome and were recorded after 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes. A digital thermometer was used. If, during the course of the study, the child's body temperature increased by 0.5 C above baseline the patient was considered to be a treatment failure.It was recorded whether the child was crying, irritable or shivering before each temperature measurement. A summary profile of the study is shown in Figure 1.The sample size was calculated on the basis of 90% statistical power and an error margin of 0.05. Epi Info version 6 was used to perform the analysis. Student's t-test was used to compare the means of the axillary temperatures in each group, calculated for each observation time. The chi-squared test was used for categorical variables. A p-value of < 0.05 was used as the cutoff point for statistical significance.No pharmaceutical laboratories had any role in the study design, data collection or analysis, or writing of the paper.
RESULTSDuring the six-month study period, 876 children were treated for fever in the emergency department between the hours of 5:00 and 7:00 p.m. 756 children were ineligible for the trial: 385 were unable to stay in the emergency ward for a minimum of two hours; 193 fulfilled at least one exclusion criterion, which most often consisted of having received an antipyretic within the previous six hours; and the remaining 178 did not meet the inclusion criteria. Among the 120 eligible children, all were given parental consent for enrollment in the study. Of these, 60 received dipyrone plus tepid sponging and 60 received dipyrone alone (controls). The distribution of the child...