The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial

Abstract

BackgroundWe aimed to compare the antipyretic efficacy, safety, and tolerability between oral dexibuprofen and intravenous propacetamol in children with upper respiratory tract infection (URTI) presenting with fever.MethodsPatients aging from 6 months to 14 years admitted for URTI with axillary body temperature ≥ 38.0 °C were enrolled and randomized into the study or control group. Patients in the study group were intravenously infused with propacetamol and subsequently oral placebo medication was administered. Patients in the control group were intravenously infused with 100 mL of 0.9% sodium chloride solution without propacetamol and then oral dexibuprofen was administered. We checked the body temperature of all patients at 0.5 h (hr), 1 h, 1.5 h, 2 h, 3 h, 4 h, and 6 h after oral placebo or dexibuprofen had been applied.ResultsA total of 263 patients (125 in the study group) were finally enrolled. The body temperatures of patients in the study group were significantly lower until 2 h after administration (37.73 ± 0.58 vs 38.36 ± 0.69 °C (p < 0.001), 37.37 ± 0.53 vs 37.88 ± 0.69 °C (p < 0.001), 37.27 ± 0.60 vs 37.62 ± 0.66 °C (p < 0.001), 37.25 ± 0.62 vs 37.40 ± 0.60 °C (p = 0.0452), at 0.5 h, 1 h, 1.5 h, and 2 h, respectively). The two groups showed no significant differences in terms of the range of body temperature decrease, the Area Under the Curve of body temperature change for antipyretic administration-and-time relationship, the maximum value of body temperature decrease during the 6 h test period, the number of patients whose body temperature normalized (< 37.0 °C), the mean time when first normalization of body temperature, and the development of adverse events including gastrointestinal problem, elevated liver enzyme, and thrombocytopenia.ConclusionsIntravenous propacetamol may be a safe and effective choice for pediatric URTI patients presenting with fever who are not able to take oral medications or need faster fever control.Trial registrationCRIS KCT0002888. Date of registration: July 31st, 2013.

Effects of Acetaminophen or Ibuprofen Monotherapy in Febrile Children: A Meta-Analysis of Randomized Controlled Trials

“…Of the remaining 34 articles, we further excluded 9 because they did not compare acetaminophen and ibuprofen monotherapies. Finally, 26 RCTs were included in this systematic review and meta-analysis [7,[12][13][14][15][16][17][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45]. The flow of article selection is illustrated in Figure 1.…”

Nonsteroidal anti‐inflammatory drugs in acute viral respiratory tract infections: An updated systematic review

“…Table 1 demonstrates the summarized results of other NSAIDs. 31 , 41 , 42 , 43 , 44 , 45 , 46 , Two studies included inpatient participants: one in adults and one in children. Five remaining studies were conducted in adult outpatient settings.…”

“…Table 1 demonstrates the summarized results of other NSAIDs 31, 41–46 ,. Two studies included inpatient participants: one in adults and one in children.…”

Comparative evaluation of the efficacy of intravenous paracetamol and ibuprofen on the treatment of tonsillopharyngitis with fever: A prospective, randomized controlled, double-blind clinical trial

“…concluded that IV propacetamol can act as a safe and effective agent for pediatric URTI patients who present with fever complaints, are unable to take oral medication, or are need of quicker fever control. [ 15 ] A clinical trial with 400 pediatric patients treated with oral or IV acetaminophen showed that fever values were lower in the IV paracetamol group at the 4 th h, with no difference in fever values at the 6 th h.[ 16 ] Another study investigating the superiority of ibuprofen against placebo in patients with malaria-induced fever revealed that fever could be controlled through 400 mg IV ibuprofen. [ 17 ] Overall, these studies indicate that drugs in IV form act faster and exert more antipyretic effectiveness than oral administration because of rapid circulation in the ED.…”