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

Riest 2006.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 360
Country: Germany
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: morphine PCA
Pain score collection: not reported
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Spinal, breast and orthopaedic surgery

  2. Aged 18‐88 years old

  3. General anaesthesia


Exclusion criteria
  1. Mental or physical inability to handle a PCA

  2. ASA > 3

  3. Opioid abuse

  4. Renal disease

Interventions Group Perioperative (180 participants): rofecoxib 50 mg preoperatively and on postoperative days 1–3
Group Postoperative (180 participants): placebo preoperatively and rofecoxib on postoperative days 1–3
Outcomes
  1. Postoperative pain (0‐4 scale at 12, 24, 48 and 72 hours postoperatively)

  2. Morphine consumption (mg at 12, 24, 48 and 72 hours postoperatively)

  3. Opioid adverse events (0‐4 scale at 12, 24, 48 and 72 hours postoperatively)

  4. Patient satisfaction (0‐4 scale at 12, 24, 48 and 72 hours postoperatively)

Notes Funding: "This work was supported financially by MSD, Germany. MSD did not participate in either generations of hypothesis, data collection, analysis or writing" up the manuscript.
Declarations of interest: as above
Authors contacted: no
Other: unable to include pain, opioid adverse events and patient satisfaction due to 0‐4 scale. Although multiple participant exclusions, data table for morphine consumption stated data from 540 patients.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "Randomization of study medications was performed
by the hospital’s pharmacy using a computer generated random list".
Allocation concealment (selection bias) Low risk Pharmacy‐controlled. Quote: "Randomization of study medications was performed
by the hospital’s pharmacy using a computer generated random list".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinded. Quote: "To ensure blinding the study drugs were delivered as coated tablets in blister packages not allowing identification of content".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Likely blinded from above information
Incomplete outcome data (attrition bias)
All outcomes High risk 90 patients excluded before outcome assessment. Quote: "We secondarily excluded 90 of the 630 patients before assessment of the primary criteria for to the following reasons: cancellation of surgery after the first dose of the study medication, administration of NSAIDs, steroids or opioids other than morphine during the study period, patients’ desire to be excluded from the study before assessment of the main outcome criteria (24 h after skin closure), patients’ discharge before assessment of main criteria, and sedation for mechanical ventilation at time of assessment of the main criteria".
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Unclear risk No baseline characteristics. Industry funded but stated no involvement