Farkas 1992.
Methods | Randomized, double‐blind, double‐placebo, placebo‐ and active‐controlled Medication administered when baseline pain reached at least moderate intensity |
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Participants | Type of surgery: abdominal aortic repair Propacetamol group Entered/completing: 29/15 Age (mean, SD): 64.3 ± 2.2 Sex (male, %): 3 Dipyrone group Entered/completing: 30/21 Age (mean, SD): 62.4 ± 1.7 Sex (male, %): 20 Placebo group Entered/completing: 30/15 Age (mean, SD): 64.3 ± 1.8 Sex (male, %): 3 |
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Interventions | Intervention: 2 g propacetamol over 2 min Control: 2.5 g dipyrone plus 0.01 g pitofenone IV Placebo: not described |
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Outcomes | Pain intensity (5‐point VRS) Requirement for rescue analgesia (morphine) |
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Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes: demographics, baseline postoperative pain score | |
Details of preoperative pain | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization table |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Investigator who did not know the nature of the products, infused the test products to each patient according to their number of entry into the trial. The patients were then monitored in the recovery room over six hours by the same investigator who did not know the nature of the product administered". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Post‐rescue assessments imputed using LOCF; imbalance amongst groups in number of participants withdrawn due to requirement for rescue analgesia |
Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section |
Size | High risk | Fewer than 50 participants per arm of the study (29 propacetamol, 30 dipyrone, 30 placebo) |