Trial reportEuropean journal of pain (London, England)2018
Efficacy and safety of a fixed-dose combination of ibuprofen and caffeine in the management of moderate to severe dental pain after third molar extraction.
Trial report in European journal of pain (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 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
- Lack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.Current drug safety · 2023Trial
- The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.Advances in therapy · 2020Trial
- Pharmacokinetic Properties of Ibuprofen (IBU) From the Fixed-Dose Combination IBU/Caffeine (400/100 mg; FDC) in Comparison With 400 mg IBU as Acid or Lysinate Under Fasted and Fed Conditions-Data From 2 Single-Center, Single-Dose, Randomized Crossover Studies in Healthy Volunteers.Clinical pharmacology in drug development · 2019Trial
- Effect of Caffeine on the Bioavailability and Pharmacokinetics of an Acetylsalicylic Acid-Paracetamol Combination: Results of a Phase I Study.Advances in therapy · 2019Trial
- Can oral caffeine decrease postoperative opioid consumption following posterior spinal fusion in adolescent idiopathic scoliosis? A randomized placebo-controlled trial.North American Spine Society journal · 2025Article
- Impact of postoperative flurbiprofen axetil on renal function in spontaneously hypertensive rats.Frontiers in pharmacology · 2025Article
- TRPA1, TRPV1, and Caffeine: Pain and Analgesia.International journal of molecular sciences · 2024Review
- Ibuprofen intake after apicoectomy-Quantitative indicator for postoperative pain.Journal of clinical and experimental dentistry · 2023Article
- Correlation of effectiveness and tolerability assessments from a pharmacy-based observational study investigating the fixed-dose combination of 400 mg ibuprofen plus 100 mg caffeine for the treatment of acute headache.Frontiers in neurology · 2023Article
- Review
- Mental Performance and Sport: Caffeine and Co-consumed Bioactive Ingredients.Sports medicine (Auckland, N.Z.) · 2022Review
- Caffeine: What Is Its Role in Pain Medicine?Cureus · 2022Review
- Single-Dose Ibuprofen-Arginine as a Preventive for Pain, Edema, and Trismus After Impacted Lower Third Molar Surgery: A Randomized Split-Mouth Clinical Trial.European journal of dentistry · 2022Article
- Antibiotics Efficiency in the Infection Complications Prevention after Third Molar Extraction: A Systematic Review.Dentistry journal · 2022Review
- Impact of the Neck and/or Shoulder Pain on Self-reported Headache Treatment Responses - Results From a Pharmacy-Based Patient Survey.Frontiers in neurology · 2022Article
- Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain-A Practical Review.Journal of clinical medicine · 2021Review
- Can paracetamol lower stress and anxiety by blunting emotions during and after computer guided dental implant surgeries? Findings from a randomized crossover clinical trial.Journal of dental sciences · 2021Article
- A Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Lysinate in Comparison to Ibuprofen Acid for Acute Postoperative Dental Pain.Pain and therapy · 2020Article
- Investigating the Effects of Ibuprofen on the Gene Expression Profile in Hippocampus of Mice Model of Alzheimer's Disease through Bioinformatics Analysis.Iranian journal of pharmaceutical research : IJPR · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIbuprofen is an effective analgesic treatment with a ceiling effect at doses above 400 mg. This study compared the combination of ibuprofen 400 mg and caffeine 100 mg with ibuprofen 400 mg monotherapy, caffeine and placebo in the analgesic treatment of moderate to severe acute dental pain following third molar extraction.
methodsPhase III, active-/placebo-controlled, double-blind, single-centre, two-stage, parallel-group study in adult patients with at least moderate baseline pain intensity. Primary endpoint was defined as the time-weighted sum of pain relief and pain intensity difference over 8 h (SPRID0-8 h), secondary endpoints included duration of pain relief, time to meaningful pain relief and more.
resultsN = 748 patients were enrolled and N = 562 treated. Mean baseline pain intensity was 7.7 on a 0-10 numerical rating scale. Analysis of SPRID0-8 h demonstrated superior analgesic effects for a single dose of ibuprofen/caffeine versus ibuprofen, caffeine and placebo over 8 h, rescue medication in this stage was requested by more patients on ibuprofen (32.5%) than on ibuprofen/caffeine (16.0%). Median time to meaningful pain relief was shorter for ibuprofen/caffeine (1.13 h) compared with ibuprofen (1.78 h; p = 0.0001). More patients on ibuprofen/caffeine than on ibuprofen reported meaningful pain relief. Adverse events were infrequent and mostly mild or moderate across treatment groups. Tolerability was rated as 'very good' or 'excellent' by most patients in both treatment groups.
conclusionThis study demonstrated clinically relevant superiority of ibuprofen/caffeine over monotherapy with ibuprofen in patients with acute dental pain. All treatments were well tolerated. SIGNIFICANCE: This trial showed superior efficacy of 400/100 mg ibuprofen/caffeine, compared to 400 mg ibuprofen alone, for treating acute pain, reflecting that caffeine is an effective analgesic adjuvant. Data on efficacy of 400 mg ibuprofen combined with caffeine for the treatment of acute pain were not available yet.
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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.