Kara 2010.
Methods | Randomized, active‐controlled study, multiple dose, evaluated up to 2 days postop Medication administered at the end of the operation, without being contingent upon pain intensity Rescue medication (meperidine/pethidine 1 mg/kg IM) given to both groups as rescue medication for VAS > 4 |
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Participants | Type of surgery: trans‐urethral resection of prostate Paracetamol group Entered/completing: 25/25 Age (mean, SD): only median age reported (64.3) Sex (male, %): 25 (100%) Diclofenac group Entered/completing: 25/25 Age (mean, SD): only median reported (66.8) Sex (male, %): 25 (100%) |
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Interventions | Paracetamol 1 g/100 ml IV over 15 min twice daily Diclofenac IM 75 mg at the end of the operation, followed by 75 mg IM for 24 h. Time interval between first two 75 mg doses not reported, but the authors describe this regimen as 150 mg once per day = 150 mg per 24 h. |
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Outcomes | Primary: pain intensity (VAS) Secondary: hemoglobin levels, hemostatic variables (bleeding time PT, INR), adverse effects, rescue opioid use (pethidine) |
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Source of funding | Not mentioned | |
Were treatment groups comparable at baseline? | Yes: demographics; duration of surgery; transrectal ultrasound volume | |
Details of preoperative pain | Similar at baseline | |
Notes | No statistically/clinically significant differences in postoperative hemoglobin, hemostatic parameters or bleeding events between placebo, paracetamol, and diclofenac groups. Diclofenac dosing (2 x 75 mg given in presumably quick succession, then repeated as a 150 mg dose 24 h later) is highly idiosyncratic, high. This regimen could bias results towards a greater diclofenac effect in the first portion of the 24 h dosing interval, and a lesser effect towards the end, compared with a more conventional dosing regimen of 75 mg IM every 12 h. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | High risk | Not described. Assessed as high risk based on assumption of non‐blinding. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not described; assume to be unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts or protocol violations |
Selective reporting (reporting bias) | Unclear risk | All outcomes from Methods section reported in Results section; opioid use reported in Results but not specifically mentioned in Methods. No SD reported for VAS data. |
Size | High risk | Fewer than 50 participants per arm of the study (25 paracetamol, 25 diclofenac) |