Kaczmarzyk 2010.
Study characteristics | ||
Methods | Study design: parallel‐group randomized controlled trial
Sample size: 64
Country: Poland
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: no opioid used Pain score collection: self‐report Concurrent postoperative analgesics: paracetamol PRN |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group Pre (34 participants): 100 mg ketoprofen PO 60 minutes preoperatively, followed by 100 mg placebo PO 60 minutes postoperatively Group Post (30 participants): 100 mg placebo PO 60 minutes preoperatively, followed by 100 mg ketoprofen PO 60 minutes postoperatively |
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Outcomes |
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Notes | Funding: "Grant of the Jagiellonian University (K/ZDS/00519)" Declarations of interest: none declared Authors contacted: no Other: pain data extracted from graphs and SD estimated. Pain score from 2 hours to allow postoperative dosing time to take effect |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table. Quote: "Each envelope contained the group assignment for one patient, which was determined in advance by a random number table". |
Allocation concealment (selection bias) | Low risk | Sealed and opaque envelopes. Quote: "One hundred opaque, sequentially numbered envelopes were used for the concealed allocation of patients to trial groups". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy placebo. Quote: "The patients, the statistician and the surgeon performing the qualification, operative procedure and follow‐up examination were all blinded with regard to which patients had received which form of treatment...Identical, nonmarked capsules with 100 mg ketoprofen or 100 mg placebo were prepared and coded in a professional pharmaceutical laboratory". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Likely blinded from above as self‐report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only two dropouts from post group, unlikely to cause bias. Quote: "one hundred patients entered the trial, of whom 4 did not check‐in for the follow‐up examination. In all, complete data sets from 96 patients were statistically analysed". |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Low risk | Similar baseline characteristics |