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

Fleckenstein 2016.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 45
Country: Germany
Setting: secondary care
Dates conducted: February 2006 to December 2011
Postoperative opioid used and delivery: morphine PCA
Pain score collection: not reported
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Aged ≥ 18 years old

  2. Abdominal or thoracic surgery

  3. ASA 1 or 2


Exclusion criteria
  1. Severe cardiac, pulmonary, renal or neurologic diseases

  2. Type 1 diabetes

  3. Diseases influencing the peripheral nervous system (e.g. polyneuropathy, chronic pain syndromes)

  4. Regional anaesthesia

  5. Use of analgesics

  6. Pregnancy or lactation

  7. Uncontrolled hypertension

  8. Contraindications listed in the product information of etoricoxib

Interventions Group 1 (unclear number of participants): PO etoricoxib 120 mg on morning of surgery then PO etoricoxib 120 mg/day for 3 days and postoperative placebo
Group 3 (unclear number of participants): placebo on morning of surgery then PO etoricoxib 120 mg/day etorocoxib for 3 days
Outcomes
  1. Morphine consumption (mg consumed at 1, 2, 4 hours and day 1‐3)

  2. Postoperative pain (on 0‐10 cm VAS and DGSS pain questionnaire during the first 48 hours)

  3. Quantitative sensory testing (various parameters at 48 hours)

Notes Funding: MSD Sharp and Dome (industry)
Declarations of interest: none declared
Authors contacted: yes
Other: standard deviation from post‐incision group estimated from preventive group. Data extracted from graph. Pain score data not reported. Participant numbers unclear but estimated from total number of participants receiving etoricoxib. Some information extracted from published protocol
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Pharmacy‐controlled. Quote: "sequentially numbered envelopes containing two boxes of study medication for pre‐ and postoperative use performed by pharmacy"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. The pills were similar in appearance.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "analysis of all records is performed by blinded evaluators".
Incomplete outcome data (attrition bias)
All outcomes High risk Patients lost to follow‐up and some for high pain. Quote: "six out of the eight dropouts (75%) because of increased pain were part of the placebo group".
Selective reporting (reporting bias) High risk NCT00716833 and published protocol. Pain data not fully reported
Other bias Unclear risk No separate data to assess. Industry funding but stated not involved in study