Table 1

Study criteria

Inclusion and exclusion criteria
Inclusion criteria
  • Male and female adult patients, ages 18–80 years, prescribed TRAM/DKP FDC for moderate to severe acute pain.

  • Patients willing to give consent for the study.

Exclusion criteria
  • Hypersensitivity to dexketoprofen, to any other NSAID, or to any of the excipients.

  • Patients in whom substances with a similar action (eg, acetylsalicylic acid or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic oedema.

  • Known photo allergic or phototoxic reactions during treatment with ketoprofen or fibrates.

  • Patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding ulceration or perforation.

  • Patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

  • Patients with chronic dyspepsia.

  • Patients who have other active bleeding or bleeding disorders.

  • Patients with Crohn’s disease or ulcerative colitis.

  • Patients with a history of bronchial asthma (even if not drug induced).

  • Patients with severe heart failure.

  • Patients with moderate to severe renal dysfunction (creatinine clearance <59 mL/min).

  • Patients with severely impaired hepatic function (Child-Pugh C).

  • Patients with haemorrhagic diathesis and other coagulation disorders.

  • Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

  • Hypersensitivity to tramadol or to any of the excipients.

  • Acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products.

  • Patients receiving MAO inhibitors or who have taken them within the last 14 days.

  • Patients with epilepsy not adequately controlled by treatment.

  • Severe respiratory depression.

  • Pregnancy and lactation.

  • FDC, fixed-dose combination; MAO, monoamine oxidase inhibitors; NSAIDs, non-steroidal anti-inflammatory drugs; TRAM/DKP, tramadol and dexketoprofen trometamol.