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

Grifka 2008.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 89
Country: unclear
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: PO oxycodone
Pain score collection: blinded investigator
Concurrent postoperative analgesics: paracetamol
Participants Inclusion criteria
  1. Male or female outpatients

  2. Aged at least 18 years

  3. Minor ambulatory arthroscopic knee surgery


Exclusion criteria
  1. Allergy to narcotics, NSAIDs or COX‐2 inhibitors

  2. Drug or alcohol abuse

  3. Peptic ulcer

  4. Gastroesophageal reflux disease

  5. Inflammatory bowel disease

  6. Cardiovascular, hepatobiliary, pancreatic and renal disorders

  7. Anticoagulants and antiplatelets (except low‐dose aspirin)

  8. Pregnant or breastfeeding

Interventions Group Preemptive (45 participants): 400 mg PO lumiracoxib one hour before the start of surgery and a placebo tablet 15 minutes after surgery
Group Postoperative (44 participants): placebo tablet one hour before surgery and 400 mg PO lumiracoxib given 15 minutes after surgery
Outcomes
  1. Postoperative pain at rest and movement (on 0‐100 mm VAS at 1, 2, 3, 4 and 24 hours)

  2. Number of patients requiring rescue medication (paracetamol and oxycodone use in 24 hours)

  3. Time to first rescue medication (hours)

  4. Global evaluation of response to treatment (four‐point Likert scale)

  5. Adverse events (incidence during follow‐up of cardiac disorders, angina, abdominal pain, vomiting and headache)

Notes Funding: not reported
Declarations of interest: not reported but some authors from pharmaceutical company
Authors contacted: yes
Other: data estimated from median and SD estimated from other studies. Analgesic consumption not added as included paracetamol. Although time to analgesic reported as time‐to‐event, not enough information to calculate summary statistics. Cardiac adverse events not included as not clearly defined. Not enough reported information to include satisfaction
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No mention
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. Quote: "...patients in the first group received a single dose of lumiracoxib 400 mg 1 hour before surgery and a placebo tablet 15 min after surgery (Pre‐emptive group)".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "patients, investigators, persons performing the assessments, data analysts and clinical team members were blinded to the identity of the treatment".
Incomplete outcome data (attrition bias)
All outcomes Low risk Intention‐to‐treat analysis
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias High risk More females in pre‐emptive group (Gerbershagen 2014). Industry involvement but unclear on role