Spreadbury 1980.
| Methods | RCT No specific consent "as not double‐blind" Protocol changed to restrict the trial to patients > 80 years in view of poor surgical results in the Ketamine group |
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| Participants | Orthopaedic hospital in Warwick, England
60 previously ambulant female patients with a proximal femoral fracture
Mean age 84 years (range not stated)
Male: % not stated Nail/plate (45%) or arthroplasty (55%) Number lost to follow‐up: none |
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| Interventions | Atropine 0.6 mg, with analgesics and oral diazepam as required Treatment group: Ketamine anaesthesia with ketamine 2 mg/kg at induction then ketamine 1 mg/kg as required. Also optional diazepam (n = 30) Control group: General anaesthesia using drugs and method chosen by the anaesthetist. Twenty patients received neuromuscular blocking agents (n = 30) Postoperative analgesia with papaveretum or pethidine ans supplemental oxygen for 24 hours |
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| Outcomes | Mortality during hospital stay Length of hospital stay (for patients discharged home only) Returned home Unsatisfactory surgical results (unstable nail/plate or prosthesis dislocation) | |
| Notes | Length of follow‐up: not stated Presence/absence of thromboprophylaxis not mentioned Total number of patients taken as the denominator for the outcome "return home" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly allocated", no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up mentioned up to 14 days. |
| Selective reporting (reporting bias) | Low risk | The authors provided results for all measurements, no evidence of selective reporting. |
| Other bias | High risk | More certified (versus in training) surgeons for the older patients in the ketamine group Unclear exactly how many patients came from home. Not in intention‐to‐treat for all results |