Trial reportThe journal of headache and pain2015
Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain.
Trial report in The journal of headache and pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01307020 (Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction), which is not on this map. Cited by 33 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.
Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Ibuprofen for acute postoperative pain in children.The Cochrane database of systematic reviews · 2024Pooled it
- Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1).Advances in therapy · 2024Trial
- Trial
- Trial
- Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial.Medicina oral, patologia oral y cirugia bucal · 2016Trial
- Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.British journal of anaesthesia · 2016Trial
- Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy.BMC anesthesiology · 2016Trial
- Adverse events of oral analgesics after third molar extraction: A network meta-analysis of randomized controlled trials.Medicina oral, patologia oral y cirugia bucal · 2026Article
- Article
- Analgesic Effect of a Novel Intravenous Ibuprofen-Low-Dose Tramadol Combination: A Multimodal Approach to Moderate-to-Severe Postoperative Dental Pain.Pharmaceutics · 2025Article
- Present and Future of Pharmacological Management for Acute Moderate-to-Severe Postoperative, Traumatic, or Musculoskeletal Pain in Europe: A Narrative Review.Pain and therapy · 2024Review
- Analgesic efficiency of dexketoprofen trometamol in third molar surgery: a systematic review and meta-analysis.Journal of dental anesthesia and pain medicine · 2024Review
- Article
- Combination Drug Therapy for the Management of Chronic Neuropathic Pain.Biomolecules · 2023Review
- Review
- Critical Appraisal of Current Acute LBP Management and the Role of a Multimodal Analgesia: A Narrative Review.Pain and therapy · 2023Review
- Review
- Artificial intelligence algorithms predict the efficacy of analgesic cocktails prescribed after orthopedic surgery.PloS one · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 12 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCombination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective.
methodsThis was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours.
results606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72%) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95% confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable.
conclusionsDexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae.
trial registrationEudraCT (2010-022798-32); Clinicaltrials.gov (NCT01307020).
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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.