---
title: "Ibuprofen vs Acetaminophen for Acute Mild-to-Moderate Pediatric Pain: Systematic Review and Meta-a"
id: "pubmed-42704487"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42704487"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42704487/"
doi: "10.1007/s00431-026-07383-7"
published_at: "2026-09-07T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Ibuprofen vs Acetaminophen for Acute Mild-to-Moderate Pediatric Pain: Systematic Review and Meta-a
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42704487
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42704487/)
- **DOI:** [10.1007/s00431-026-07383-7](https://doi.org/10.1007%2Fs00431-026-07383-7)
- **Published At:** 2026-09-07T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This systematic review and meta-analysis assessed randomized controlled trials comparing **ibuprofen** and **acetaminophen** for acute mild-to-moderate pain in children and adolescents (0 to <18 years). - A systematic search through May 2026 of PubMed, Scopus, and Web of Science identified eight randomized controlled trials enrolling a total of **1325 participants**. - Primary continuous pain outcome meta-analysis included three pediatric trials (n = 196 analyzable participants) and produced a pooled effect size of **SMD -0.28 (95% CI -0.57 to 0.00; p = 0.052; I2 = 0%)**, indicating a small effect favoring ibuprofen that did not reach conventional statistical significance. - Dichotomous pain freedom outcome (2 trials, n = 114) showed no significant difference (pooled RR 1.03, 95% CI 0.53–1.99; p = 0.93; I2 = 0%). - A prespecified sensitivity analysis adding an adult soft-tissue injury trial reduced the pooled effect toward null (SMD -0.15, 95% CI -0.38 to 0.09; p = 0.23; I2 = 36.6%). - Narrative synthesis of additional pediatric studies generally found **comparable analgesic efficacy** between the two agents across postoperative and outpatient settings; an inflammatory pain etiology (e.g., fractures) may show a greater ibuprofen advantage. - Risk of bias was assessed with Cochrane RoB 2 and overall certainty of evidence was rated **low** using GRADE, mainly due to imprecision and indirectness. - Authors conclude no demonstrated superiority of ibuprofen over acetaminophen in pediatric acute mild-to-moderate pain and recommend individualized agent selection based on contraindications, pain etiology, and patient factors. - The review highlights the need for adequately powered, methodologically rigorous pediatric trials to define comparative efficacy definitively.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliations * 1 Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy. * 2 Università Degli Studi di Milano, Milan, Italy. * 3 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. * 4 Pediatric Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. * 5 Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy. * 6 Department of Woman and Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italy. * 7 Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy. * 8 IRCCS Azienda Ospedaliera Metropolitana, Genoa, Italy. * 9 Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. giocip@me.com. * PMID: **42704487** * DOI: [ 10.1007/s00431-026-07383-7 ](https://doi.org/10.1007/s00431-026-07383-7) Item in Clipboard Review # Ibuprofen versus acetaminophen for acute mild-to-moderate pain management in pediatric populations: a systematic review and meta-analysis of their efficacy Gian Luigi Marseglia et al. Eur J Pediatr. 2026. Show details Display options Display options Format Abstract PubMed PMID Eur J Pediatr Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Eur+J+Pediatr%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Eur+J+Pediatr%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42704487/) . 2026 Sep 7;185(9):723. doi: 10.1007/s00431-026-07383-7. ### Authors [Gian Luigi Marseglia](https://pubmed.ncbi.nlm.nih.gov/?term=Marseglia+GL&cauthor_id=42704487)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-1 "Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy."), [Paola Giovanna Marchisio](https://pubmed.ncbi.nlm.nih.gov/?term=Marchisio+PG&cauthor_id=42704487)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-2 "Università Degli Studi di Milano, Milan, Italy.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-3 "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy."), [Gregorio Paolo Milani](https://pubmed.ncbi.nlm.nih.gov/?term=Milani+GP&cauthor_id=42704487)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-4 "Pediatric Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.")[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-5 "Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy."), [Michele Miraglia Del Giudice](https://pubmed.ncbi.nlm.nih.gov/?term=Miraglia+Del+Giudice+M&cauthor_id=42704487)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-6 "Department of Woman and Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italy."), [Irene Schiavetti](https://pubmed.ncbi.nlm.nih.gov/?term=Schiavetti+I&cauthor_id=42704487)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-7 "Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.")[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-8 "IRCCS Azienda Ospedaliera Metropolitana, Genoa, Italy."), [Giorgio Ciprandi](https://pubmed.ncbi.nlm.nih.gov/?term=Ciprandi+G&cauthor_id=42704487)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42704487/#short-view-affiliation-9 "Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. giocip@me.com.") ### Affiliations * 1 Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy. * 2 Università Degli Studi di Milano, Milan, Italy. * 3 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. * 4 Pediatric Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. * 5 Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy. * 6 Department of Woman and Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italy. * 7 Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy. * 8 IRCCS Azienda Ospedaliera Metropolitana, Genoa, Italy. * 9 Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. giocip@me.com. * PMID: **42704487** * DOI: [ 10.1007/s00431-026-07383-7 ](https://doi.org/10.1007/s00431-026-07383-7) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract Ibuprofen and acetaminophen are the most widely used analgesics in pediatric practice for the management of acute mild-to-moderate pain. Despite their widespread use, the comparative analgesic efficacy of these two agents in children remains a subject of ongoing debate, with existing evidence largely derived from heterogeneous clinical settings and small individual trials. Therefore, this study aimed to systematically review and meta-analyze randomized controlled trials comparing the analgesic efficacy of ibuprofen versus acetaminophen in pediatric populations with acute mild-to-moderate pain. A systematic literature search was conducted up to May 2026 in PubMed, Scopus, and Web of Science. The review was conducted and reported in accordance with the PRISMA-Children and Adolescents (PRISMA-C) 2026 reporting guideline. Eligible studies were randomized controlled trials comparing ibuprofen with acetaminophen in children and adolescents (defined as individuals aged 0 to < 18 years) with acute pain, reporting at least one extractable efficacy outcome. Continuous outcomes were synthesized as standardized mean differences (Hedges' g) using random-effects models; dichotomous outcomes were pooled as risk ratios (RRs) with 95% confidence intervals. Risk of bias was assessed using the Cochrane RoB 2 tool and certainty of evidence was evaluated using the GRADE framework. Eight randomized controlled trials enrolling 1325 participants were included. Three pediatric trials contributed to the primary continuous pain outcome meta-analysis (n = 196 analyzable participants), yielding a pooled SMD of - 0.28 (95% CI - 0.57 to 0.00; p = 0.052; I2 = 0%), indicating a small effect favoring ibuprofen that did not reach conventional statistical significance. Given the small number of contributing studies (k = 3), the I2 statistic should be interpreted with caution as it has limited power to detect heterogeneity in this context. For the dichotomous pain freedom outcome (2 trials, n = 114), no significant difference was observed (pooled RR 1.03, 95% CI 0.53-1.99; p = 0.93; I2 = 0%). A prespecified sensitivity analysis including an adult soft-tissue injury trial attenuated the pooled effect toward the null (SMD - 0.15, 95% CI - 0.38 to 0.09; p = 0.23; I2 = 36.6%). Narrative synthesis of additional studies generally demonstrated comparable analgesic efficacy between the two agents across postoperative and outpatient pediatric settings. The overall certainty of evidence was rated as low for both primary outcomes, primarily due to imprecision and indirectness. **Conclusion:** Current evidence from randomized controlled trials does not demonstrate a superiority of ibuprofen over acetaminophen for acute mild-to-moderate pain management in children. Both agents appear to provide clinically meaningful analgesia across heterogeneous pediatric pain settings. The clinical choice between agents should be guided by individual patient factors, including contraindications to NSAIDs, the inflammatory nature of the pain etiology, and patient-specific characteristics. The low certainty of evidence underscores the need for adequately powered, methodologically rigorous trials to definitively establish the comparative efficacy of these two analgesics in the pediatric population. **What is known:** • Ibuprofen and acetaminophen are the two most widely used non-opioid analgesics for acute mild-to-moderate pain in children, and both are recommended as first-line agents by major international guidelines. • Prior meta-analyses in mixed pediatric-adult populations have suggested a modest analgesic advantage of ibuprofen over acetaminophen, but pediatric-specific evidence has remained limited and methodologically heterogeneous. **What is new:** • This systematic review and meta-analysis, restricted to randomized controlled trials in pediatric populations, found that ibuprofen showed a small effect favoring pain reduction compared with acetaminophen (SMD - 0.28, p = 0.052), although this did not reach conventional statistical significance. • The analgesic advantage of ibuprofen may be more pronounced in pain etiologies with a significant inflammatory component (e.g., fractures). At the same time, both agents appear broadly equivalent in most other acute pediatric pain settings, supporting individualized analgesic selection based on clinical context and patient-specific factors. **Keywords:** Acetaminophen; Acute pain; Ibuprofen; Meta-analysis; Paracetamol; Pediatrics; Randomized controlled trial; Systematic review. © 2026. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declarations. Ethics approval: Not applicable for a review article. Competing interests: The authors have no relevant financial or non-financial interests to disclose, but GPM received an unrestricted grant from Angelini Pharma and Reckitt Benckiser Healthcare. Moreover, he participated in an advisory board supported by an unrestricted grant from Angelini Pharma. ## References 1. 1. Bailey B, Trottier ED (2016) Managing pediatric pain in the emergency department. Paediatr Drugs 18(4):287–301 - [DOI](https://doi.org/10.1007/s40272-016-0181-5) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/27260499/) 2. 1. Zhu A, Benzon HA, Anderson TA (2017) Evidence for the efficacy of systemic opioid-sparing analgesics in pediatric surgical populations: a systematic review. Anesth Analg 125(5):1569–1587 - [DOI](https://doi.org/10.1213/ane.0000000000002434) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/29049110/) 3. 1. Ferland CE, Vega E, Ingelmo PM (2018) Acute pain management in children: challenges and recent improvements. Curr Opin Anaesthesiol 31(3):327–332 - [DOI](https://doi.org/10.1097/aco.0000000000000579) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/29432292/) 4. 1. Ducharme J (2000) Acute pain and pain control: state of the art. Ann Emerg Med 35(6):592–603 - [DOI](https://doi.org/10.1016/s0196-0644\(00\)70033-3) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/10828773/) 5. 1. Maunuksela EL, Olkkola KT (1991) Pediatric pain management. Int Anesth Clin 29(1):37–55 - [DOI](https://doi.org/10.1097/00004311-199102910-00006) Show all 34 references ## Publication types * Systematic Review Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Systematic+Review%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Systematic+Review) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42704487/) * Meta-Analysis Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Meta-Analysis%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov
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