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

Bunemann 1994.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 117
Country: Denmark
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: IV pethidine
Pain score collection: in recovery (unclear who) and 24 hour self‐report
Concurrent postoperative analgesics: paracetamol
Participants Inclusion criteria
  1. ASA 1 or 2

  2. Minor orthopaedic surgery


Exclusion criteria
  1. Allergy to NSAIDs

  2. Pregnancy

  3. NSAID treatment within 14 days

  4. Opioids

  5. Hypoglycaemics

  6. Sedatives

  7. Lithium

  8. Psychiatric drugs

  9. Peptic ulcer

  10. Age < 18 and > 60 years old

Interventions Group TP (59 participants): naproxen 1100 mg one hour before surgery and placebo immediately after surgery
Group PT (58 participants): placebo one hour before surgery and naproxen 1100 mg immediately after surgery
Outcomes
  1. Postoperative pain (0‐100 mm VAS in PACU, discharge and at 24 hours)

  2. Analgesia consumption (paracetamol and pethidine consumption in PACU and at 24 hours)

  3. Side effects (no details reported on timing or actual side effects measured)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: pain scores estimated from median and interquartile range; analgesic consumption not included as not just opioid consumed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details reported
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "naproxen sodium 1100 mg 1 h before surgery and placebo immediately after surgery"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Six exclusions, although unclear which groups. Ten missing for 24‐hour data. Quote: "six had to be excluded; three because they did not have an operation and three because they did not have general anaesthesia".
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Low risk Similar baseline characteristics