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

Flath 1987.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 28
Country: USA
Setting: dental medical school
Dates conducted: not reported
Postoperative opioid used and delivery: none
Pain score collection: patient self‐report
Concurrent postoperative analgesics: not reported
Participants Inclusion criteria
  1. Age 20‐80 years

  2. Non‐surgical endodontic therapy


Exclusion criteria
  1. Root canal therapy complicated by sclerotic or bayonet‐shaped canals

  2. ASA 3, 4 or 5

  3. Long‐term steroid or immunosuppressant therapy

  4. Pregnancy

  5. Recent administration of analgesics

Interventions Group C (13 participants): 100 mg flurbiprofen 30 minutes before procedure and placebo 3 hours after surgery
Group B (15 participants): placebo 30 minutes before procedure and 100 mg flurbiprofen 3 hours after surgery
Outcomes
  1. Postoperative pain (0‐100 mm VAS and categorical rating scale at 3, 7 and 24 hours)

  2. Adverse events (gastrointestinal, central nervous and other during follow‐up)

Notes Funding: 'The Upjohn Company provided no financial support for this study’
Declarations of interest: not reported
Authors contacted: no
Other: pain score data extracted from graph. Three‐hour data not included as this was when postoperative administration occurred. SD estimated. Pain score data only included symptomatic preoperative patients.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random draw of envelopes. Quote: "By random draw"
Allocation concealment (selection bias) Unclear risk No details regarding the envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "Placebos and the flurbiprofen (The Upjohn Co Kalamazoo, MI) were compounded into identical blue tablets".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Likely blinded as patient self‐report and blinded intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk Only four dropouts, unlikely to cause bias. Quote: "...of the 120 patients enrolled in the study, 116 completed all phases".
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar baseline characteristics. No industry funding