Siddik 2001.
Methods | Randomized, double‐blind, double‐dummy, placebo‐ and active‐controlled Medications administered immediately after surgery |
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Participants | Type of surgery: cesarean delivery Propacetamol group Entered/completing: 20/20 Age (mean, SD): 31 ± 4.6 Sex (male, %): 0 Diclofenac group Entered/completing: 20/20 Age (mean, SD): 31.4 ± 6 Sex (male, %): 0 Placebo group Entered/completing: 20/20 Age (mean, SD): 30.6 ± 5.1 Sex (male, %): 0 |
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Interventions | Intervention: 2 g propacetamol Control: 100 mg rectal diclofenac Control: combination of 100 mg rectal diclofenac and 2 g propacetamol (not included in our analysis) Placebo: double‐dummy, exact details not described |
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Outcomes | Opioid consumption (morphine via PCA) Pain intensity at rest and on coughing (VAS 0 to 10) Global assessment (categorical, at 24 h) |
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Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes: age, weight, height, parity, and gestationaΙ age | |
Details of preoperative pain | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
Allocation concealment (selection bias) | Unclear risk | Patients and staff were unaware of the patients' group assignment |
Blinding (performance bias and detection bias) All outcomes | Low risk | "to ensure blinding of both the parturients and the anaesthesiologist, patients in all groups received both an IV injection and a suppository during the same period" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | From 80 patients one was excluded due to technical problems of the PCA device. Data obtained from the 79 remaining patients were used for the analysis of all outcomes and time points. |
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 (20 propacetamol, 20 diclofenac, 20 placebo) |