Colbert 1998.
Study characteristics | ||
Methods | Study design: parallel‐group randomized controlled trial Sample size: 77 Country: Ireland Setting: secondary care Dates conducted: July 1996 to December 1996 Postoperative opioid used and delivery: IM pethidine Pain score collection: blinded investigator Concurrent postoperative analgesics: diclofenac or paracetamol |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group A (37 participants): 20 mg IV tenoxicam 30 minutes before surgery Group B (40 participants): 20 mg IV tenoxicam post‐incision |
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Outcomes |
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Notes | Funding: not reported Declarations of interest: not reported Authors contacted: no Other: analgesic consumption not included as at 4 hours. Included as a pre‐emptive intervention as not all participants received diclofenac postoperatively |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers. Quote: "table of random numbers" |
Allocation concealment (selection bias) | Unclear risk | No mention |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No double‐dummy placebo. Quote: "The patients in group A received 20 mg tenoxicam IV 30 mins pre‐operatively and patients in group B received 20 mg tenoxicam IV post‐incision". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded. Quote: "outcomes were assessed by an investigator without knowledge of the timing of tenoxicam administration". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants analysed. Quote: "There were 37 patients in group A (20 mg tenoxicam and 30 min before surgery) and 40 patients in group B (20 mg tenoxicam post‐incision)". |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration |
Other bias | Low risk | Similar baseline characteristics. Quote: "There were no differences between the groups with respect to age, duration of surgery, length of the wound or the weight of the patient". |