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. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Pandazi 2010.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 40
Country: Greece
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: morphine PCA
Pain score collection: blinded anaesthetist
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Elective surgery for colorectal cancer

  2. ASA 1 or 2


Exclusion criteria
  1. Allergy to NSAIDs

  2. Peptic ulcer

  3. Coronary artery disease

  4. Severe cardiac insufficiency

  5. Renal insufficiency

  6. COPD

  7. IBD

  8. Use of analgesic medication the week before surgery

Interventions Group PRE (20 participants): 40 mg IV parecoxib 30 minutes before surgery and 100 mL saline 30 minutes after incision. Then parecoxib 40 mg BD for three days
Group POST (20 participants): 40 mg IV parecoxib 30 minutes after incision and 100 mL saline 30 minutes before surgery. Then parecoxib 40 mg BD for three days
Outcomes
  1. Postoperative pain (0‐10 VRS at 1, 6, 18 and 24 hours)

  2. Morphine consumption (mg at 1, 6, 18 and 24 hours)

  3. Nausea and vomiting (24 hours)

  4. Cytokines (IL‐6, IL‐8, and TNF‐alpha at baseline, intraoperative and 24 hours)

  5. Pruritus and respiratory depression (24 hours)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: pain scores reported as median so used as means and IQR/1.35 to convert to SD. No events for pruritus or respiratory depression
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote "Computer generated randomization list run by the hospital pharmacist"
Allocation concealment (selection bias) Low risk Pharmacy‐controlled. Quote "Computer generated randomization list run by the hospital pharmacist"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote "A trained nurse administered an intravenous (IV) solution of 100 ml normal saline with parecoxib 40 mg to group PRE (preincisional) and an IV solution of 100 ml normal saline to group POST (post‐incisional) 30 min before skin incision. The same nurse administered 100 ml normal saline with parecoxib 40 mg to group POST and 100 ml normal saline to group PRE 30 min after skin incision. The solutions were dispensed by the hospital pharmacist".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote "All participants in the study (nurse, surgeon, anesthesiologist, patients) were blinded to the perioperative intervention".
Incomplete outcome data (attrition bias)
All outcomes Low risk Only one participant excluded, unlikely to cause bias
Selective reporting (reporting bias) Unclear risk 24807/20‐12‐06 trial registration but unable to locate protocol
Other bias Low risk Similar baseline characteristics