Results
Six hundred patients were screened for study eligibility (Figure 1). Of these, 166 patients could not participate for various reasons (140 did not fulfill the inclusion criteria or met an exclusion criterion and 26 did not give their consent to participate in the trial). Therefore, a total of 434 adults were enrolled, randomized, and received the study medications, ie, oral paracetamol (n = 145), intravenous paracetamol (n = 139), and intramuscular diclofenac (n = 150). Baseline demographic and clinical characteristics were similar across the three treatment groups (P > 0.05, Table 1). The majority of the study subjects enrolled were males. This can be attributed to the location of the hospital, which caters mainly for the migrant labor community of the surrounding industrial area. The mean patient age was 36. 1 ± 15.81 years. Mean oral temperature at baseline was similar across the three treatment groups. Figure 1 shows the enrollment of participants through each stage of the trial.
After 90 minutes, all three groups showed a significant reduction in mean temperature, with intramuscular diclofenac showing the greatest (−1.44 ± 0.43, 95% confidence interval [CI] −1.4 to −2.5) and oral paracetamol the least (−1.08 ± 0.51, 95% CI −0.99 to −2.2). After 120 minutes, there was a significant difference observed in the mean change from baseline temperatures between the three treatment groups (P < 0.0001). Significant changes in temperature were observed in favor of intramuscular diclofenac over oral and intravenous paracetamol at each time point from 60 minutes through 120 minutes inclusive (Table 3). Repeated-measures ANOVA revealed a significant reduction in the change from mean baseline temperature within each treatment group, particularly at 60, 90, and 120 minutes (Table 2 and Figure 2). Patients who received intravenous fluids showed a significantly higher reduction in mean temperature from baseline, particularly at 30 minutes (−0.45 ± 0.38 versus −0.33 ± 0.34; P = 0.002) and 120 minute (−1.7 ± 0.59 versus −1.5 ± 0.51; P = 0.030) Reduction in mean temperature at the various time points was not significantly different among patients receiving antibiotics.