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. 2018 Dec 3;2018(12):CD012624. doi: 10.1002/14651858.CD012624.pub2

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
Participants Inclusion criteria
  1. Scheduled for elective colon surgery (hemicolectomy)


Exclusion criteria
  1. Severe hepatic, renal, cardiovascular, or psychological disorders

  2. Unable to rate the VAS score

  3. Unable to use the PCA pump

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
Outcomes
  1. Tramadol consumption (mg in early postoperative period)

  2. Postoperative pain (VAS on initial activation of PCA device, 2, 4, 8, 12 hours postoperatively, and the morning of the day following surgery)

  3. Time to analgesia (minutes)

  4. Drowsiness/sedation (yes/no postoperatively)

  5. Nausea and vomiting (yes/no postoperatively)

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.
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