Trial reportDrugs in R&D2020
Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.
Trial report in Drugs in R&D, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01559259 (EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN), which is not on this map. Cited by 11 papers, 2 of them syntheses 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.
Evaluation of the efficacy of novel ibuprofen acetaminophen combination formulations in the treatment of post-surgical dental pain
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Cyclooxygenase-2 selective inhibitors increase the risk of alveolar osteitis: A systematic review and meta-analysis.Medicina oral, patologia oral y cirugia bucal · 2026Pooled it
- Ibuprofen for acute postoperative pain in children.The Cochrane database of systematic reviews · 2024Pooled it
- Pain control following impacted mandibular third molar surgery: a comparison of the effectiveness of two different protocols.Scientific reports · 2025Trial
- Combination vs. single-drug nonprescription analgesics for acute pain management: A narrative review.British journal of clinical pharmacology · 2025Review
- New perspectives for optimizing fever and pain management in pediatrics: evidence supporting therapeutic awareness in clinical practice.Italian journal of pediatrics · 2025Review
- Analytical Techniques for the Determination of Paracetamol and Ibuprofen Combination.Journal of analytical methods in chemistry · 2025Review
- Efficacy and Safety of Fixed-Dose Combinations for Pain in Older Adults.Drugs & aging · 2024Review
- Steroidal Anti-Inflammatory Drugs for Oral Surgery: A Systematic Review and Meta-Analysis.Acta stomatologica Croatica · 2024Article
- Article
- Parenteral Ready-to-Use Fixed-Dose Combinations Including NSAIDs with Paracetamol or Metamizole for Multimodal Analgesia-Approved Products and Challenges.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIbuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug-drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety.
objectivesThe present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo.
methodsThis 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4]
resultsIn total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4]
conclusionEach IBU/APAP FDC provided analgesic efficacy comparable to that with ibuprofen 400 mg and superior to that with placebo. Each FDC provided MPR in < 1 h, duration of pain relief > 9 h, and tolerability similar to that with ibuprofen and placebo. CLINICALTRIALS. GOV REGISTRATION: NCT01559259.
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What OpenQuestion holds
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.