Fletcher 1997.
Methods | Randomized, double‐blind, active‐ and placebo‐controlled Medications administered at skin closure (and repeated every 6 h x 48 h) |
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Participants | Type of surgery: surgery of one herniated lumbar disc Propacetamol group Entered/completing: 15/14 Age (mean, SD): 41.8 ± 2.7 Sex (male, %): 53 Ketoprofen group Entered/completing: 15/14 Age (mean, SD): 49.7 ± 2.9 Sex (male, %): 53 Placebo group Entered/completing: 15/15 Age (mean, SD): 41.8 ± 2.4 Sex (male, %): 60 |
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Interventions | Intervention: 2 g propacetamol in 125 ml dextrose 5% Control: ketoprofen 50 mg Control: combination of ketoprofen with propacetamol (not included in our analysis) Placebo: 125 ml dextrose 5% |
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Outcomes | Pain intensity at rest and with movement (VAS) Sedation (4‐point categorical scale) |
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Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes: demographics; preoperative pain; duration of surgery | |
Details of preoperative pain | Incidence of preoperative leg and/or back pain similar between groups. Mean severity of preoperative pain similar (ranged from 42 to 51/100) between groups. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Before the study began, a random number table was used to generate a randomized schedule specifying the group to which each patient would be assigned upon entry into the trial |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | All drugs were administered IV after dilution in 125 ml dextrose 5% labeled with the randomization number of the participant. Participants in all groups received 2 injections to assure blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition rate balanced amongst groups |
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 (15 propacetamol, 15 ketoprofen, 15 placebo) |