Mimoz 2001.
Methods | Randomized, placebo‐ and active‐controlled Medications administered at completion of surgery |
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Participants | Type of surgery: hepatic resection Propacetamol group Entered/completing: unclear/38 Age (median, range): 49 (28 to 75) Sex (male, %): 40 Nefopam group Entered/completing: unclear/36 Age (median, range): 57 (21 to 75) Sex (male, %): 53 Placebo group Entered/completing: unclear/38 Age (median, range): 57 (27 to 75) Sex (male, %): 58 |
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Interventions | Intervention: 2 g propacetamol over 15 min Control: 20 mg nefopam over 60 min Placebo: no treatment |
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Outcomes | Primary: opioid consumption (morphine via PCA) Pain intensity (VAS) Patient satisfaction (categorical) |
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Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes: sex, weight, height, ASA physical status, duration of surgery and anesthesia, sufentanil and midazolam cumulative doses, VAS score at extubation, and morphine dose for titration Participants in the propacetamol group were younger versus other 2 groups. Compared with the propacetamol group, participants in the nefopam group had lower VAS scores at extubation and longer intervals between the completion of hepatic resection and extubation. |
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Details of preoperative pain | Participants receiving chronic anaΙgesic or anti‐inflammatory treatment were excluded | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | High risk | Open study |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | From 120 participants 8 were withdrawn for various reasons. Data from all remaining participants were used in the analyses. |
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 (38 propacetamol, 36 nefopam, 38 placebo) |