ArticleJournal of pain research2014
Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study.
Article in Journal of pain research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04968158 (Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.), which is not on this map. Cited by 17 papers.
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.
Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.
Who cites it
17 citing papers in PubMed, 32 citations in OpenAlex.
- Short- and Mid-Term Outcomes of Fixed-Dose Tramadol/Paracetamol in Early-Stage Symptomatic Knee Osteoarthritis: A Single-Center Retrospective Observational Extension Study.Life (Basel, Switzerland) · 2026Article
- Analgesic Effect of a Novel Intravenous Ibuprofen-Low-Dose Tramadol Combination: A Multimodal Approach to Moderate-to-Severe Postoperative Dental Pain.Pharmaceutics · 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
- Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol.Pain and therapy · 2024Article
- Drug overdose deaths during prison riots and mental states of prisoners: a case study.Frontiers in psychiatry · 2024Article
- Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review.Journal of pain research · 2022Review
- Effectiveness of ibuprofen plus paracetamol combination on persistence of acute musculoskeletal disorders in primary care patients.International journal of clinical pharmacy · 2021Article
- Opioid Therapy in Cancer Patients and Survivors at Risk of Addiction, Misuse or Complex Dependency.Frontiers in pain research (Lausanne, Switzerland) · 2021Review
- The Expanding Role of the COX Inhibitor/Opioid Receptor Agonist Combination in the Management of Pain.Drugs · 2020Review
- [Management of early rheumatoid arthritis : Interdisciplinary guideline].Zeitschrift fur Rheumatologie · 2020Review
- Tramadol/Diclofenac Fixed-Dose Combination: A Review of Its Use in Severe Acute Pain.Pain and therapy · 2020Review
- Tramadol Prescription over a 4-Year Period in the USA.Current pain and headache reports · 2019Review
- 2017 update of the Turkish League Against Rheumatism (TLAR) evidence-based recommendations for the management of knee osteoarthritis.Rheumatology international · 2018Review
- Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study - PRIME study.Journal of pain research · 2017Article
- Osteoarthritis year in review 2015: clinical.Osteoarthritis and cartilage · 2016Review
- Efficacy and safety of a fixed combination of tramadol and paracetamol (acetaminophen) as pain therapy within palliative medicine.Materia socio-medica · 2015Article
- Practice of Pain Management by Indian Healthcare Practitioners: Results of a Paper Based Questionnaire Survey.Pain research and treatment · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain.
methodsA total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.5 mg) and paracetamol (325 mg) (two tablets every 4-6 hours, up to a maximum of eight tablets daily). The primary efficacy end points were reductions in pain intensity from baseline at day 3 and day 5 as assessed by a Visual Analog Scale (VAS) score.
resultsGroup A showed a significant reduction in the VAS score for overall pain from baseline on day 3 (P=0.001) and day 5 (P<0.0001) as compared with group B. The combination of tramadol-diclofenac resulted in few mild to moderate adverse events (nausea, vomiting, epigastric pain, and gastritis), which required minimal management, without any treatment discontinuation. The number of adverse events in group A was nine (8.82%) compared with 22 (21.78%) in group B, after 5 days of treatment.
conclusionAn FDC of tramadol-diclofenac showed a significantly greater reduction in pain intensity and was well tolerated compared with tramadol-paracetamol, resulting in better analgesia in patients suffering from moderate to severe pain due to acute musculoskeletal conditions, postoperative pain following orthopedic surgery, or acute flare of osteoarthritis and rheumatoid arthritis.
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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.