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

Coli 1993.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 50
Country: Italy
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: buprenorphine
Pain score collection: not included as outcome
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. ASA 1 or 2

  2. Weighing between 50 and 90 kg

  3. Lumbar laminectomy


Exclusion criteria
  1. Aged < 18 and > 65 years old

  2. Diabetes

  3. Gastroduodenal ulcer

  4. Alcoholism

  5. Allergic to study medications

  6. Psychiatric disorders

  7. Renal and hepatic impairment

  8. Anticoagulants or antiplatelets

  9. Calcium channel blockers, beta‐blockers or angiotensin‐converting enzyme inhibitors

  10. Clonidine

  11. Psychotropic drugs

  12. NSAIDs in the 12 hours pre‐intervention

Interventions Group I (25 participants): IV sodium naproxen 550 mg immediately after induction of anaesthesia
Group II (25 participants): IV sodium naproxen 550 mg at the end of surgery
Outcomes
  1. Analgesic consumption (mg of buprenorphine consumed at 24 hours)

  2. Time to analgesic request (hours)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: article in Italian so translated. Buprenorphine consumption converted to mg intravenous morphine. Standard deviations estimated. Time to analgesic request data extracted from graph
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes High risk No double‐dummy placebo. Quote: "group I received Naproxen sodium 550 mg intravenously immediately after induction of anesthesia; group II received sodium naproxen 550 mg intravenously at the beginning of the surgical suture".
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants analysed
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Low risk Similar baseline characteristics. Quote: "The three groups were comparative to the distribution by age, weight, sex and duration of the intervention".