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. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3

Law 2000.

Methods RCT
Parallel design
Participants Location: USA
Orthodontic patients undergoing separator placement, N = 63 (including Group B)
Setting: Department of Orthodontics
Group A: 10 male, 12 female; mean age (years) 13.4 (SD 1.7)
Group C: 9 male, 13 female; mean age (years) 13.1 (SD 1.8)
Interventions Group A: 400 mg ibuprofen 1 hour preoperatively (and placebo immediately after the appointment) (N = 22)
Group C: placebo 1 hour preoperatively (and placebo immediately after the appointment) (N = 22)
All oral
Outcomes Incidence and severity of pain at different time intervals postoperatively, using a visual analogue scale
Notes We did not report Group B as this group only received postoperative painkillers
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants "randomly assigned"
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported
Blinding (performance bias and detection bias) 
 All outcomes Low risk Investigator, clinician and participants were blinded to the treatment
Incomplete outcome data (attrition bias) 
 All outcomes High risk 111 participants consented, but 28 of these did not receive separators at next appointment, and 17 participants forgot to take pretreatment dose before appointment. Trial authors did not include 3 more participants for unspecified reasons. It was unclear from the paper which groups participants were lost from
Selective reporting (reporting bias) Low risk All expected outcomes reported
Other bias Low risk None apparent