Mahran 2015.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 90, of whom 60 participants in IV ketamine and control treatment arms. 100% women | |
Interventions | Ketamine 0.5 mg/kg bolus IV before anaesthesia induction + intraoperative IV infusion 0.25 mg/kg/h till the end of skin closure | |
Outcomes | Pain intensity (VAS) reported at 30 min, 2, 4, 6, 12 and 24 h postoperatively. Cumulative analgesic consumption at 24 h. AEs | |
Surgery type | Breast cancer surgery (radical mastectomy) | |
Group numbers after end of study (treatment/control) | 30/30 | |
Age of patient population (treatment/control) | 53.1 ± 6.2 53.9 ± 8.1 |
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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 | Computer‐generated random number assignment |
Allocation concealment (selection bias) | Low risk | Allocation concealed in sequentially numbered, opaque envelopes |
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) | Low risk | All predefined dropouts reported |
Size | High risk | 30 participants per treatment arm |