Conditions: Acute Pain
Keywords: Moderate to severe acute pain Postoperative pain Abdominal hysterectomy Analgesics Dexketoprofen Tramadol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses arm 2: Dexketoprofen-single dose followed by Dexketoprofen-multiple doses arm 3: Tramadol-single dose followed by Tramadol-multiple doses arm 4: Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses arm 5: Placebo single dose followed by Dexketoprofen-multiple doses arm 6: Placebo single dose followed by Tramadol-multiple doses

Interventions: intervention 1: Placebo intervention 2: Dexketoprofen-single dose intervention 3: Tramadol-single dose intervention 4: Dexketoprofen/Tramadol-single dose intervention 5: Dexketoprofen-multiple doses intervention 6: Tramadol-multiple doses intervention 7: Dexketoprofen/Tramadol-multiple doses
Intervention descriptions: intervention 1: Placebo single oral dose (first 8 hours) intervention 2: Dexketoprofen single oral dose (first 8 hours) intervention 3: Tramadol single oral dose (first 8 hours) intervention 4: Dexketoprofen/Tramadol single oral dose (first 8 hours) intervention 5: Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses) intervention 6: Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses) intervention 7: Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Protocol document: