Trial reportBMC pediatrics2018
The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial.
Trial report in BMC pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Nonsteroidal anti-inflammatory drugs in acute viral respiratory tract infections: An updated systematic review.Pharmacology research & perspectives · 2022Pooled it
- Effectiveness and safety of rectal dexibuprofen versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants with gestational age<34 weeks: A pilot study.International journal of immunopathology and pharmacologyTrial
- The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen.Journal of clinical medicine · 2025Article
- Evaluation of the Regulatory Required Post-Authorization Safety Study for Propacetamol: Nested Case-Control and Case-Time-Control Studies.Yonsei medical journal · 2024Article
- A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization.Scientific reports · 2022Article
- Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.Paediatric drugs · 2022Review
- Letter to the Editor: Propacetamol-Induced Rhabdomyolysis or COVID-Vaccine-Related Inflammatory Myopathy?Journal of Korean medical science · 2022Article
- Evaluation of efficacy and safety of subcutaneous acetaminophen in geriatrics and palliative care (APAPSUBQ).BMC palliative care · 2022Article
- Effects of acetaminophen and ibuprofen monotherapy in febrile children: a meta-analysis of randomized controlled trials.Archives of medical science : AMS · 2022Review
- Identification of compounds with antipyretic effects and anti-endotoxin activity in different species ofExperimental and therapeutic medicine · 2021Article
- 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.Turkish journal of emergency medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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