Dataset Information

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

ABSTRACT: 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.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).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<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups.The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy.EudraCT 2012-004548-31 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004548-31);ClinicalTrials.gov NCT01902134 (https://www.clinicaltrials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1).

SUBMITTER: McQuay HJ

PROVIDER: S-EPMC4718147 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

McQuay H J HJ Moore R A RA Berta A A Gainutdinovs O O Fülesdi B B Porvaneckas N N Petronis S S Mitkovic M M Bucsi L L Samson L L Zegunis V V Ankin M L ML Bertolotti M M Pizà-Vallespir B B Cuadripani S S Contini M P MP Nizzardo A A

British journal of anaesthesia 20160201 2

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 26787797

Similar Datasets

Project description:BackgroundTramadol is increasingly used to treat acute postoperative pain among older adults following total hip and knee arthroplasty (THA/TKA). However, tramadol has a complex pharmacology and may be no safer than full opioid agonists. We compared the safety of tramadol, oxycodone, and hydrocodone among opioid-naïve older adults following elective THA/TKA.MethodsThis retrospective cohort included Medicare Fee-for-Service beneficiaries ≥ 65 years with elective THA/TKA between January 1, 2010 and September 30, 2015, 12 months of continuous Parts A and B enrollment, 6 months of continuous Part D enrollment, and no opioid use in the 6 months prior to THA/TKA. Participants initiated single-opioid therapy with tramadol, oxycodone, or hydrocodone within 7 days of discharge from THA/TKA hospitalization, regardless of concurrently administered nonopioid analgesics. Outcomes of interest included all-cause hospitalizations or emergency department visits (serious adverse events (SAEs)) and a composite of 10 surgical- and opioid-related SAEs within 90-days of THA/TKA. The intention-to-treat (ITT) and per-protocol (PP) hazard ratios (HRs) for tramadol versus other opioids were estimated using inverse-probability-of-treatment-weighted pooled logistic regression models.ResultsThe study population included 2,697 tramadol, 11,407 oxycodone, and 14,665 hydrocodone initiators. Compared to oxycodone, tramadol increased the rate of all-cause SAEs in ITT analyses only (ITT HR 1.19, 95%CLs, 1.02, 1.41; PP HR 1.05, 95%CLs, 0.86, 1.29). Rates of composite SAEs were not significant across comparisons. Compared to hydrocodone, tramadol increased the rate of all-cause SAEs in the ITT and PP analyses (ITT HR 1.40, 95%CLs, 1.10, 1.76; PP HR 1.34, 95%CLs, 1.03, 1.75), but rates of composite SAEs were not significant across comparisons.ConclusionsPostoperative tramadol was associated with increased rates of all-cause SAEs, but not composite SAEs, compared to oxycodone and hydrocodone. Tramadol does not appear to have a superior safety profile and should not be preferentially prescribed to opioid-naïve older adults following THA/TKA.

Project description:IntroductionRecently the DAVID study demonstrated the better analgesic efficacy of tramadol hydrochloride/dexketoprofen 75/25 mg (TRAM/DKP) over tramadol hydrochloride/paracetamol 75/650 mg (TRAM/paracetamol) in a model of moderate to severe acute pain following surgical removal of an impacted third molar. The aim of this subpopulation analysis was to gain a deeper understanding of the relationship between baseline pain intensity (PI) level and the effectiveness in pain control of the TRAM/DKP combination in comparison with the TRAM/paracetamol combination. This will further improve and facilitate the accurate design of future acute pain studies for the use of the TRAM/DKP combination.MethodsPatients experiencing at least moderate pain, defined as a PI score ≥ 4 in an 11-point numerical rating scale (NRS) were stratified according to NRS-PI at baseline (NRS ≥ 4, 5, 6, 7, or 8) or aggregated in two groups: (i) moderate pain, NRS-PI ≥ 4 to ≤ 6; (ii) severe pain, NRS-PI > 6. Analgesic efficacy was assessed at pre-specified time points by using pain relief (PAR) on a 5-point verbal rating scale (VRS) and PI on an 11-point NRS. The primary endpoint was total PAR over 6 h post-dose (TOTPAR6); secondary endpoints included, among others, the time course of mean PAR and PI scores over 8 h, TOTPAR over 2, 4, and 8 h post-dose, and the sum of PI difference (SPID) over 2, 4, 6, and 8 h. Safety evaluation was based on the incidence, seriousness, intensity, and causal relationship of treatment-emergent adverse events (TEAEs).ResultsThe analgesic efficacy evaluated by TOTPAR6 (primary endpoint) remained steady across increasing baseline PI-NRS cutoff groups with TRAM/DKP, but not with TRAM/paracetamol. The study also demonstrated the superiority of TRAM/DKP combination over TRAM/paracetamol in terms of TOTPAR over 2, 4, and 8 h post-dose and SPID at 2, 4, 6, and 8 h post-dose in both baseline PI groups (moderate or severe); similarly, the time course of PAR and PI indicated better efficacy with TRAM/DKP as soon as 30 min and up to 4-6 h. The incidence of adverse drug reactions was not increased in the severe baseline PI group.ConclusionOverall, the results of this subgroup analysis of the DAVID study confirmed the superiority of the analgesic efficacy of TRAM/DKP vs TRAM/paracetamol, irrespective of the baseline PI.

Project description:Background The growing number of patients undergoing total hip arthroplasty (THA) and postoperative outcomes receive increasing attention from doctors and patients. This study aimed to elucidate the effects of comorbidities on postoperative function, pain, complications, readmission rate, and mortality. Methods We included consecutive patients who underwent primary unilateral THA between 2017 and 2019. The Charlson comorbidity index (CCI) and the WOMAC and SF-36 (physical function, body pain) scales were assessed preoperatively and at 3, 6, 12, and 24 months postoperatively. The complications, 30-day readmission, and mortality rates assessed the impact of comorbidities and their changes over time on the WOMAC and SF-36 scores during follow-up. We used mixed model linear regression to examine the association of worsening comorbidity post-THA with change in WOMAC and SF-36 scores in the subsequent follow-up periods, controlling for age, length of follow-up, and repeated observations. Results This study included 468 patients, divided into four groups based on comorbidity burden (CCI-0, 1, 2, and ≥3). The physiological function recovery and pain scores in the CCI ≥ 3 group were inferior to the other groups and took longer than the other groups (6 vs. 3 months) to reach their best level. The four groups preoperative waiting times were 2.41 ± 0.74, 2.97 ± 0.65, 3.80 ± 0.53, and 5.01 ± 0.71 days, respectively. The complications, 30-day readmission, and 1-year mortality rates for the overall and the CCI ≥ 3 group were 1.92% and 4.69%, 0.85% and 2.01%, and 0.43% and 1.34%, respectively, with no mortality in the other groups. Conclusion Patients with higher CCI were more susceptible to physical function and pain outcome deterioration, experienced longer waiting time before surgery, took longer to recover, and had higher rates of complications, 30-day readmission, and mortality after THA. Older age in the group led to a greater impact.

Project description:OBJECTIVES:To compare efficacy/safety of oral tramadol 75?mg/dexketoprofen 25?mg (TRAM/DKP) and TRAM 75?mg/paracetamol 650?mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar. DESIGN:Multicentre, randomised, double-blind, placebo-controlled, phase IIIb study. PARTICIPANTS:Healthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis. INTERVENTIONS:Surgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (?4) within 4?hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25?mg, TRAM/paracetamol 75/650?mg or placebo. MAIN OUTCOME MEASURES:Efficacy was based patients' electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0='no relief', 1='a little (perceptible) relief', 2='some (meaningful) relief', 3='lot of relief', 4='complete relief') at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6?hours (TOTPAR6). Rescue medication was available during the treatment period. RESULTS:TRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.2 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups. CONCLUSIONS:TRAM/DKP (75/25?mg) is effective and superior to TRAM/paracetamol (75/650?mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile. TRIAL REGISTRATION NUMBER:EudraCT 2015-004152-22 and NCT02777970.

Project description:BackgroundGroin pain is a common long-term complication of total hip arthroplasty (THA). Femoral head size has been proposed as one of the primary causes. The implants used in dual mobility (DM) THA have large outer-bearing articulations, which could increase the risk of post-operative groin pain. Hip resurfacing (HR), too, has been shown to be associated with a risk of groin pain.Questions/purposesThe goals of this study were to compare the incidence of groin pain at 1 year after hip arthroplasty in patients with different femoral head diameters and in patients undergoing conventional THA, DM THA, and HR.MethodsAfter combing an institutional registry for all patients who had undergone THA or HR for primary hip osteoarthritis, we included 3193 patients in the analysis; 2008 underwent conventional THA, 416 underwent DM THA, and 769 underwent HR. We used logistic regression modeling to analyze the relation of groin pain at 1 year after surgery to patient demographics and clinical characteristics, including age, sex, body mass index (BMI), University of California at Los Angeles activity score at 1 year after surgery, bearing couple, and the ratio of acetabular diameter to femoral head diameter. We also measured cup inclination and anteversion in a subset of patients with and without groin pain at 1 year to assess whether pain could be related to implant position.ResultsOverall, 8.7% of patients reported groin pain at 1 year. Patients with groin pain were younger and had lower BMIs. There were increased odds of groin pain with a greater cup-to-head ratio, although DM implants, interestingly, were not significantly associated with groin pain; this may be attributable to so much of their movement taking place inside the implant. Subgroup analysis measuring cup inclination and anteversion showed no difference in cup position between patients with and without pain.ConclusionIn this population of hip arthroplasty patients, the incidence of groin pain 1 year after surgery did not differ among patients undergoing DM and conventional THA; DM THA in particular was not associated with a higher risk of groin pain, despite its comparatively larger femoral head sizes. HR, on the other hand, was associated with a higher risk of pain. Appropriate implant sizing and bearing couple choice may optimize the functional benefit of THA.

Dataset Information

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

Publications

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets