Van Aken 2004.
Methods | Randomized, double‐blinded, double‐dummy, placebo‐ and active‐controlled Medication administered when baseline pain reached moderate‐to‐severe intensity within 3 h after regaining consciousness |
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Participants | Type of surgery: dental Propacetamol group Entered/completing: 31/31 Age (mean, SD): 20.0 ± 4.9 Sex (male, %): 25 Morphine group Entered/completing: 30/30 Age (mean, SD): 18.8 ± 4.3 Sex (male, %): 39 Placebo group Entered/completing: 34/34 Age (mean, SD): 20.9 ± 6.6 Sex (male, %): 29 |
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Interventions | Intervention: 2 g propacetamol in 150 ml normal saline over 15 min Control: 10 mg morphine Placebo: 150 ml normal saline |
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Outcomes | Pain intensity (VRS, VAS) and derived summary measures Pain relief (VRS) Proportion of patients requesting and time to rescue medication (morphine) Global assessment (at 10 h) |
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Source of funding | Supported by a grant from Bristol‐Myers Squibb | |
Were treatment groups comparable at baseline? | Yes: demographics, duration of surgery, baseline pain intensity No: the morphine group had a larger proportion of ASA II participants than the placebo group (P value < 0.01) |
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Details of preoperative pain | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐dummy technique employed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | From 99 patients 4 were excluded due to protocol violations before any data had been collected. "All 95 remaining patients from whom efficacy data were obtained were included in the efficacy analysis". |
Selective reporting (reporting bias) | Unclear risk | All outcome from Methods section reported in Results section |
Size | High risk | Fewer than 50 participants per arm of the study (31 propacetamol, 30 morphine, 34 placebo) |