Leal 2013.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 40, about 83% women | |
Interventions | Ketamine 5 µg/kg/min infusion IV until wound closure | |
Outcomes | Pain intensity (NRS) reported every 30 min up to 4 h, then every 6 h up to 24 h postoperatively. Time to the first analgesic supplementation. Cumulative analgesic consumption reported at 24 h postoperatively. AEs | |
Surgery type | Laparoscopic cholecystectomy | |
Group numbers after end of study (treatment/control) | 20/20 | |
Age of patient population (treatment/control) | 46 ± 12.5 45.5 ± 16.1 |
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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) | Low risk | Randomisation achieved by drawing envelopes |
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) | High risk | AEs are defined and reported in 'results' section, but not predefined in 'methods' section |
Size | High risk | 20 participants per treatment arm |