Sahin 2004.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 47, of whom 33 participants in IV ketamine and control treatment arms. About 52% women | |
Interventions | Pre‐incisional ketamine 0.5 mg/kg bolus IV | |
Outcomes | Pain intensity (VAS), reported in 15‐min intervals during the 1st h. Cumulative analgesic consumption reported at 24 h postoperatively. Time to first analgesic request. AEs | |
Surgery type | Lumbar discectomy | |
Group numbers after end of study (treatment/control) | 17/16 | |
Age of patient population (treatment/control) | 46.5 ± 7.3 48.3 ± 11.2 |
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Notes | 3 study groups. The treatment group received ketamine bolus IV + remifentanil intraoperatively. The 2nd group where participants received saline bolus IV + remifentanil intraoperatively served as a control group. The 3rd group (14 participants) received saline bolus IV + saline infusion intraoperatively and was excluded from the analysis. 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) | Unclear risk | Allocation concealment method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded personnel |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | Predefined outcomes reported but misses exact numbers of PONV, only mentioned that the incidences of nausea, vomiting were similar among groups |
Size | High risk | 17 and 16 participants per treatment arm |