This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only). Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely: * DKP/TRAM followed by DKP/TRAM; * DKP followed by DKP; * TRAM followed by TRAM; * placebo followed by DKP; * placebo followed by TRAM; * placebo followed by DKP/TRAM; The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo. The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
606
Placebo single oral dose (first 8 hours)
Dexketoprofen single oral dose (first 8 hours)
Tramadol single oral dose (first 8 hours)
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Time frame: over 8 hours after the first dose
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Time frame: over 8 hours after first dose
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Time frame: over 48 hours of the multiple-dose phase
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
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Dexketoprofen/Tramadol single oral dose (first 8 hours)
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Bajcsy-Zsilinszky Kórház
Budapest, Hungary
University Hospital of Debrecen
Debrecen, Hungary
Dr. Bugyi István Kórház
Szentes, Hungary
Fejér megyei Szent György Kórház
Székesfehérvár, Hungary
Juras Medicinas Centre
Riga, Latvia
Riga East University Hospital Gynecology Clinic
Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Lithuania
Vilniaus gimdymo namai
Vilnius, Lithuania
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, Lublin Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
...and 18 more locations
Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS \< 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase. The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Time frame: over 48 hours of the multiple-dose phase