Martinez 2007.
Study characteristics | ||
Methods | Study design: parallel‐group randomized controlled trial Sample size: 41 Country: France Setting: secondary care Dates conducted: not reported Postoperative opioid used and delivery: morphine PCA Pain score collection: blinded nurse Concurrent postoperative analgesics: none reported |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group Pre (22 participants): 40 mg IV parecoxib at induction, placebo at wound closure and 40 mg IV parecoxib at 12 hours Group Post (19 participants): placebo at induction, 40 mg IV parecoxib at wound closure and 40 mg IV parecoxib 12 hours after surgery |
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Outcomes |
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Notes | Funding: NIH Grant GM 061655 (Bethesda, MD), the Gheens Foundation (Louisville, KY), the Joseph Drown Foundation (Los Angeles, CA) and the Commonwealth of Kentucky Research Challenge Trust Fund (Louisville, KY). No financial support of Pfizer Declarations of interest: not reported Authors contacted: no Other: pain score data for 24 hours extracted from graph and SD estimated. Time to analgesic request not time‐to‐event |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated. Quote: "computer‐generated codes" |
Allocation concealment (selection bias) | Low risk | Quote: "the randomization instructions were stored in sequentially numbered opaque envelopes opened the day of surgery before induction of anesthesia". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy placebo used. Quote: "...all patients received three IV injections: one with anesthesia induction, a second at wound closure, and a third 12 hours after induction". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Fourteen exclusions. Quote: "Eleven patients were eliminated from the study: two patients withdrew consent, one required prolonged postoperative mechanical ventilation, two were inadvertently given paracetamol (one of the exclusion criterion), four because of inadequate order of treatment attribution (third injection made instead the second), one had a surgical complication that required intervention, and one because the patient’s data were lost...Two additional patients were eliminated from the study after morphine titration in the PACU". |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration |
Other bias | Low risk | Similar baseline characteristics and no drug company involvement |