Deng 2009.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 200, about 43% women | |
Interventions |
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Outcomes | Pain intensity (VAS) reported at 24 h postoperatively. PCA remifentanil consumption, reported at 0‐12 h, 12‐24 h and 0‐24 h postoperatively. AEs. Participant satisfaction with analgesia | |
Surgery type | Lower limb fracture operation | |
Group numbers after end of study (treatment/control) | 150/50 | |
Age of patient population (treatment/control) | 49.6 ± 5.6 50.1 ± 6.3 |
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Notes | No mention of sponsorship or funding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment method not described in detail |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded personnel |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals not reported |
Selective reporting (reporting bias) | Low risk | Predefined outcomes addressed |
Size | Unclear risk | 50 participants per treatment arm |