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
Exclusion criteria
|
|
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 |
|
|
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 |