Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty
| Autor: | László Bucsi, M. Mitkovic, S. Cuadripani, Monica Bertolotti, Sandris Petronis, B. Piza Vallespir, Narūnas Porvaneckas, O. Gainutdinovs, Henry J McQuay, R A Moore, M. L. Ankin, A. Berta, L. Samson, Béla Fülesdi, Andrea Nizzardo, M. P. Contini, V. Zegunis |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Male
Arthroplasty Replacement Hip medicine.medical_treatment Severity of Illness Index law.invention 0302 clinical medicine Randomized controlled trial law Clinical endpoint Medicine 030212 general & internal medicine Tromethamine Aged 80 and over Pain Postoperative Anti-Inflammatory Agents Non-Steroidal Orvostudományok Middle Aged Metamizole Analgesics Opioid Treatment Outcome Ketoprofen Anesthesia analgesics Drug Therapy Combination Female Tramadol Total hip arthroplasty medicine.drug tramadol Adult Moderate to severe arthroplasty replacement hip dexketoprofen trometamol pain postoperative medicine.medical_specialty Analgesic Pain Klinikai orvostudományok Placebo 03 medical and health sciences Double-Blind Method Humans Aged business.industry Dexketoprofen Arthroplasty Confidence interval Surgery Anesthesiology and Pain Medicine business 030217 neurology & neurosurgery |
| Zdroj: | British journal of anaesthesia, Oxford : Oxford University Press, 2016, Vol. 116, no 2, p. 269-276 BJA: British Journal of Anaesthesia |
| ISSN: | 0007-0912 1471-6771 |
| Popis: | Background. The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty. Methods. This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8). Results. Overall, 641 patients, mean age 62 (range 29–80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4–73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5–76). The single components were superior to placebo (P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|