Köse 2012.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 150, of whom 120 participants in IV ketamine and control treatment arms. About 74% women | |
Interventions | Ketamine 0.1 mg/kg OR ketamine 0.25 mg/kg OR ketamine 0.5 mg/kg bolus IV 20 mins before the end of surgery. Heterogeneous surgery types | |
Outcomes | Pain intensity (VAS) reported at 0, 1 and 2 h postoperatively. Time to first analgesic request. AEs. Postoperative shivering | |
Surgery type | Various operations under general anaesthesia | |
Group numbers after end of study (treatment/control) | 90/30 | |
Age of patient population (treatment/control) | 41.2 ± 12 44.5 ± 9.2 |
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Notes | Primary endpoint was postoperative shivering. No mention of sponsorship or funding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation process not described |
Allocation concealment (selection bias) | Low risk | Allocation in closed envelopes, identical study drug syringes prepared and labelled by an independent investigator not participating in the further study |
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 investigator made assessments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Low risk | Predefined outcomes reported |
Size | High risk | 30 participants per treatment arm |