Trial reportEuropean journal of clinical pharmacology2021
Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study.
Trial report in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00699114 (Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine), which is not on this map. Cited by 12 papers.
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.
Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery
Who cites it
12 citing papers in PubMed, 21 citations in OpenAlex.
- Dexketoprofen Time-Dependent Administration After Third Molar Extraction: A Pilot Randomized Cross-Over Controlled Trial.Clinical and experimental dental research · 2026Trial
- Comparison of analgesic efficacy of ibuprofen and dexketoprofen in pain management of long bone fractures: a prospective, randomized, double-blind study.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024Trial
- Perioperative loxoprofen sodium is associated with lower pain and anxiety levels in dental implant surgery: a cohort study in China.Clinical oral investigations · 2026Article
- Review
- 3D printing of acetaminophen suppository and its quality and pharmacokinetic evaluation.3D printing in medicine · 2025Article
- Acute Pain Management Following Mandibular Third Molar Exodontia: A Bibliometric Analysis of Randomized Controlled Trials.International dental journal · 2025Article
- Intravenous vs. Oral Dose Comparison of Ibuprofen and Tramadol Combinations-Enantiomers, Metabolite, Linearity, and Sex-Related Effects: A Pharmacokinetics Randomized Clinical Trial.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Comparative study of the effects of ibuprofen, acetaminophen, and codeine in a model of orofacial postoperative pain in male and female rats.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Spectroscopic Analysis of the Effect of Ibuprofen Degradation Products on the Interaction between Ibuprofen and Human Serum Albumin.Current protein & peptide science · 2024Article
- Stem cells and pain.World journal of stem cells · 2023Review
- Article
- Indian Society of Periodontology Good Clinical Practice Recommendations for dental pain management and use of analgesics.Journal of Indian Society of PeriodontologyReview
Corrections and comments
- Commented on by
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeEffect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates.
methodsA randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp.
resultsIbuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose-response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs.
conclusionIbuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators.
trial registrationNCT00699114.
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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.