ReviewPaediatric drugs2017
Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months.
Review in Paediatric drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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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
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Symptomatic fever management in children: A systematic review of national and international guidelines.PloS one · 2021Pooled it
- Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years: A Systematic Review and Meta-analysis.JAMA network open · 2020Pooled it
- Ibuprofen dosing measurement accuracy using infants' versus children's ibuprofen: a randomized crossover comparison.Pediatric research · 2023Trial
- Adverse Event Profiles of Acetaminophen and Ibuprofen in Infants: A Food and Drug Administration Adverse Event Reporting System Database Retrospective Cohort Study.Turkish archives of pediatrics · 2025Article
- AILDE Computer-Aided Discovery of Novel Ibuprofen-Coumarin Antitumor Lead Compounds Targeting Cyclooxygenase-2.ACS omega · 2024Article
- Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.Paediatric drugs · 2022Review
- Development of the Swiss Database for dosing medicinal products in pediatrics.European journal of pediatrics · 2022Article
- Pharmacometric Analysis of Intranasal and Intravenous Nalbuphine to Optimize Pain Management in Infants.Frontiers in pediatrics · 2022Article
- Pediatric Perioperative Clinical Pharmacy Practice: Clinical Considerations and Management: An Opinion of the Pediatrics and Perioperative Care Practice and Research Networks of the American College of Clinical Pharmacy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Paracetamol and Ibuprofen in the Treatment of Fever and Acute Mild-Moderate Pain in Children: Italian Experts' Consensus Statements.Children (Basel, Switzerland) · 2021Review
- Management of acute fever in children: Consensus recommendations for community and primary healthcare providers in sub-Saharan Africa.African journal of emergency medicine : Revue africaine de la medecine d'urgence · 2021Review
- Developmental Pharmacokinetics and Safety of Ibuprofen and Its Enantiomers in the Conventional Pig as Potential Pediatric Animal Model.Frontiers in pharmacology · 2019Article
- Safety of ibuprofen in infants younger than six months: A retrospective cohort study.PloS one · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ibuprofen is a non-steroidal anti-inflammatory drug frequently administered to children of various ages for relief of fever and pain and is approved as an over-the-counter medication in many countries worldwide. Although there are extensive data on its efficacy and safety in children and adults, there are divergent dosing recommendations for analgesia and treatment of fever in infants, especially in the age group between 3 and 6 months of age. In this article, we have assessed the safety and efficacy of ibuprofen use in infants in an attempt to find the optimal method of pain and fever management in this specific age group. Based on the current evidence, short-term use of ibuprofen is considered safe in infants older than 3 months of age having a body weight above 5-6 kg when special attention is given to the hydration of the patient. Ibuprofen should be prescribed based on body weight using a dose of 5-10 mg/kg. This dose can be administered 3-4 times a day resulting in a maximum total daily dose of 30-40 mg/kg. The rectal route has been shown to be less reliable because of erratic absorption, especially in young infants. Since most efficacy and safety data have been derived from trials in infants with fever, future studies should focus on the efficacy of ibuprofen in young infants with pain.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.