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

Autor: Seung Jun Choi, Sena Moon, Ui Yoon Choi, Yoon Hong Chun, Jung Hyun Lee, Jung Woo Rhim, Jin Lee, Hwang Min Kim, Dae Chul Jeong
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: BMC Pediatrics, Vol 18, Iss 1, Pp 1-7 (2018)
Druh dokumentu: article
ISSN: 1471-2431
DOI: 10.1186/s12887-018-1166-z
Popis: Abstract Background We 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. Methods Patients 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. Results A 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
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