Landwehr 2005.
Methods | Randomized, double‐blinded, placebo‐ and active‐controlled Medications administered 30 min before arrival in the recovery area |
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Participants | Type of surgery: retinal Propacetamol group Entered/completing: 12/12 Age (mean, SD): 52 ± 18 Sex (male, %): 67 Metamizole group Entered/completing: 13/13 Age (mean, SD): 60 ± 19 Sex (male, %): 31? (data reported in error) Placebo group Entered/completing: 13/13 Age (mean, SD): 58 ± 22 Sex (male, %): 69 |
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Interventions | Intervention: 1 g paracetamol in 100 ml over 15 min Active control: 1 g metamizol Placebo: 100 ml normal saline |
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Outcomes | Pain intensity at rest and on coughing (VRS, VAS) Opioid consumption (tilidine) Patient satisfaction (categorical) |
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Source of funding | The study was in part financed by a grant from Bristol‐Myers Squibb GmbH, München, Germany | |
Were treatment groups comparable at baseline? | Yes: demographics | |
Details of preoperative pain | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated code |
Allocation concealment (selection bias) | Low risk | Code prepared at a remote site and sealed in sequentially numbered, opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Infusions were made to look identical |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants in placebo group had incomplete data, imputed by LOCF. It appears that all other participants contributed data at all time points for all outcomes. |
Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section. Some adverse event data listed only as P values. |
Size | High risk | Fewer than 50 participants per arm of the study (12 propacetamol, 13 metamizole, 13 placebo) |