Mercadante 2000.
Methods | Stated to be randomised but procedure not described. Blinded study: Drugs prepared in identical syringes by a person not involved in the test sessions Placebo control Cross‐over Study duration: 30 to 180 minutes |
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Participants | Cancer patients with neuropathic pain unrelieved by morphine N = 10 per group (cross‐over) Mean age of patients: 57 years |
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Interventions | Treatment 1:
Saline (IV) Treatment 2: KET bolus 0.25 mg/kg (IV) Treatment 3: KET bolus 0.5 mg/kg (IV) |
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Outcomes | Pain intensity
Adverse effects Results: Low‐dose KET IV + Mo (PO, SC, IV) significantly reduced pain intensity |
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Notes | Washout period ( "at least two days") Quality/ validity: OPVS score: 12 Oxford score: 3 Information on funding not provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated to be randomised but procedure not described. |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The drugs were prepared in identical syringes by a person not involved in the test sessions". Blinding possibly compromised due to adverse effects from ketamine. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No specific procedure to check for detection bias. Possible bias due to adverse effects from ketamine |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
Selective reporting (reporting bias) | Low risk | No problems detected |
Size | High risk | Fewer than 50 participants in total (cross‐over) |