Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar (DAVID)
Acute Pain
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Acute pain, Acute moderate to severe pain, Postoperative pain, Dexketoprofen Tramadol, Dexketoprofen trometamol, Tramadol hydrochloride, Multimodal analgesia, Third molar extraction, Fixed drug combination, Paracetamol, Analgesics
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
- Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
- Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).
Exclusion Criteria:
- History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
- History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
- Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.
Sites / Locations
- Dr. Tóth Bagi Zoltán Fogászati Rendeloje
- OralMed Studio Fogászati és Szájsebészeti Kft.
- Szegedi Tudományegyetem
- Ospedale Civile San Salvatore di L'Aquila
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliero-Universitaria Pisana
- Azienda Ospedaliera Universitaria Integrata
- Ars-Dent
- Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic
- Charme Clinique Klinika Stomatologii
- Centro Medico Teknon
- Hospital Médico Quirúrgico de Conxo
- Hospital Universitario Virgen del Rocío
- Universidad de Valencia
- Birmingham Community Healthcare NHS Foundation Trust
- University Hospital of Wales
- University of Manchester
- University Hospitals of North Midlands NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Tramadol/Dexketoprofen
Tramadol/Paracetamol
Placebo
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose; Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose.
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose; Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose. .
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose; Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.