Law 2000.
Methods | RCT Parallel design |
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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) |
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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 |
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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 |