Etropolski 2011.
| Methods | Randomised controlled trial 4‐arm parallel group design Trial duration: 8 weeks Randomisation stratified according to study centre Multicentre trial with 84 centres No power calculation reported | |
| Participants | Participants with joint disease requiring surgery and insufficient pain relief by stable analgesic regimens were eligible 598 participants were randomised 598 participants with knee or hip osteoarthritis reported at baseline Number of females: 349 of 596 (59%) Mean age: 59 years | |
| Interventions |
Experimental interventions
Oral immediate‐release tapentadol, 50 mg 3‐6 times daily
Oral immediate‐release tapentadol, 75 mg 3‐6 times daily
Oral immediate‐release oxycodone, 10 mg 3‐6 times daily Control intervention Placebo, 3‐6 times daily Treatment duration: 2 weeks Analgesics other than study drugs allowed and intake was similar between groups |
|
| Outcomes | Extracted pain outcome: global pain after 8 weeks No function outcome reported Primary outcome: change in pain intensity | |
| Notes | Sponsor: Johnson & Johnson | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was based on a computer‐generated randomization schedule, stratified by study center, and implemented using an interactive voice response system" |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomization was based on a computer‐generated randomization schedule, stratified by study center, and implemented using an interactive voice response system" |
| Described as double‐blind? | Low risk | Quote: "In this double‐blind study, patients with end‐stage joint disease were randomized to tapentadol IR (50 mg or 75 mg), oxycodone HCL IR 10 mg, or placebo" |
| Blinding of patients? | Low risk | Quote: "All study drugs were provided as overencapsulated tablets or capsules and were identical in shape, color, and size" |
| Blinding of physicians? | Low risk | Quote from ClinicalTrials.gov: "Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)" |
| Blinding of outcome assessors? | Low risk | Because participants were blinded and outcomes were participant‐reported, the risk of detection bias was considered low |
| Interventions reported as indistinguishable? | Low risk | Quote: "All study drugs were provided as overencapsulated tablets or capsules and were identical in shape, color, and size" |
| Double‐dummy technique used? | High risk | No double‐dummy technique used |
| Intention‐to‐treat analysis performed? Pain | High risk | 2 of 306 participants excluded in experimental group, 74 of 148 participants excluded in control group |
| Intention‐to‐treat analysis performed? Function | Unclear risk | Not applicable, no function outcome reported |