Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (DAVID lap)
Acute Pain
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Moderate to severe acute pain, Postoperative pain, Abdominal hysterectomy, Analgesics, Dexketoprofen, Tramadol
Eligibility Criteria
Inclusion Criteria:
- Female patients aged 18 to 75 years.
- Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
- Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Exclusion Criteria:
- Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
- Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
- Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
- Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
- Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
- Breastfeeding women.
Sites / Locations
- Bajcsy-Zsilinszky Kórház
- University Hospital of Debrecen
- Dr. Bugyi István Kórház
- Fejér megyei Szent György Kórház
- Juras Medicinas Centre
- Riga East University Hospital Gynecology Clinic
- Hospital of Lithuanian University of Health Sciences Kaunas
- Vilniaus gimdymo namai
- Samodzielny Publiczny Szpital Kliniczny nr 1
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
- Prywatna Klinika Polozniczo-Ginekologiczna
- Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
- Wojewodzki Szpital
- Specjalistyczny Szpital im. E. Szczeklika
- Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
- Centralny Szpital Kliniczny MSW w Warszawie
- Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
- Genesys Fertility Center
- Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
- Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
- Spitalul Universitar de Urgenta Bucuresti
- Spitalul Clinic de Urgenta "Sfantul Pantelimon"
- Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
- Moscow Regional Research Institute of Obstetrics and Gynecol
- FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
- GYNPOR, s.r.o.
- Complejo Hospitalario Arquitecto Marcide
- Hospital Universitario Arnau de Vilanova
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Active Comparator
Other
Other
Other
DKP/TRAM followed by DKP/TRAM
DKP followed by DKP
TRAM followed by TRAM
Placebo followed by DKP/TRAM
Placebo followed by DKP
Placebo followed by TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Tramadol-single dose followed by Tramadol-multiple doses
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Placebo single dose followed by Dexketoprofen-multiple doses
Placebo single dose followed by Tramadol-multiple doses