Wordliczek 2002.
Methods | Study design: parallel‐group randomized controlled trial Sample size: 90 Country: Poland Setting: secondary care hospital Dates conducted: not reported Postoperative opioid used and delivery: PCA tramadol Pain score collection: not reported Concurrent postoperative analgesics: none reported |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Group I (30 participants): 100 mg IV tramadol 15 minutes before induction Group II (30 participants): 100 mg IV tramadol after peritoneal closure Group Control (30 participants): 100 mg IV tramadol immediately after operation |
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Outcomes |
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Notes | Funding: supported by grant WL/241/KL/L from Collegium Medicum Jagiellonian University, Kraków, Poland Declarations of interest: none reported Authors contacted: we contacted authors for further information but received no response. Other: only results from Group I (preventive) and control group compared. Sedation not analysed as dichotomous outcome. Time to analgesic request standard deviations estimated as unclear from graph. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details. Quote: "participants were randomly allocated into three groups" |
Allocation concealment (selection bias) | Unclear risk | No mention |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Interventions given at different times. Quote: "30 patients (I group) were administered 100 mg of tramadol iv 15 minutes before induction of general anesthesia. The patients of II group were administered 100 mg of tramadol iv immediately after peritoneal closure. In order to determine the influence of the inhibition of phase II (inflammatory response in the postoperative period) on nociceptive stimulation, patients in control group (30 patients) received 100 mg of tramadol iv immediately after operation" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Likely unblinded based on above information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of any dropouts |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration |
Other bias | Low risk | Similar baseline characteristics and no reported conflicts of interest |