Grifka 2008.
Study characteristics | ||
Methods | Study design: parallel‐group randomized controlled trial Sample size: 89 Country: unclear Setting: secondary care Dates conducted: not reported Postoperative opioid used and delivery: PO oxycodone Pain score collection: blinded investigator Concurrent postoperative analgesics: paracetamol |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group Preemptive (45 participants): 400 mg PO lumiracoxib one hour before the start of surgery and a placebo tablet 15 minutes after surgery Group Postoperative (44 participants): placebo tablet one hour before surgery and 400 mg PO lumiracoxib given 15 minutes after surgery |
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Outcomes |
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Notes | Funding: not reported Declarations of interest: not reported but some authors from pharmaceutical company Authors contacted: yes Other: data estimated from median and SD estimated from other studies. Analgesic consumption not added as included paracetamol. Although time to analgesic reported as time‐to‐event, not enough information to calculate summary statistics. Cardiac adverse events not included as not clearly defined. Not enough reported information to include satisfaction |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention |
Allocation concealment (selection bias) | Unclear risk | No mention |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy placebo used. Quote: "...patients in the first group received a single dose of lumiracoxib 400 mg 1 hour before surgery and a placebo tablet 15 min after surgery (Pre‐emptive group)". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded. Quote: "patients, investigators, persons performing the assessments, data analysts and clinical team members were blinded to the identity of the treatment". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration |
Other bias | High risk | More females in pre‐emptive group (Gerbershagen 2014). Industry involvement but unclear on role |