Baygin 2011.
Methods | RCT Parallel design |
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Participants | Location: Turkey Children needing primary molar tooth extraction, N = 45, age range 6 to 12 years Setting: paediatric dental clinic Group 1: 10 male, 5 female; mean age (years) 8.53 (standard deviation (SD) 1.60) Group 2: 8 male, 7 female; mean age (years) 9.33 (SD 1.4) Group 3: 7 male, 8 female; mean age (years) 9.33 (SD 2.2) |
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Interventions | Group 1: 100 mg/5 mL ibuprofen 30 minutes preoperatively by age (N = 15) Group 2: 250 mg/4 mL paracetamol 1 hour preoperatively by age (N = 5) Group 3: placebo 1 hour preoperatively (N = 15) All oral |
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Outcomes | 5 face scale (15 minutes, 1, 2, 3, 4, 5, 6 and 24 hours) | |
Notes | It was difficult to determine the actual dosage of painkillers given. The trial authors stated in the discussion that ibuprofen varied from 4 to 10 mg/kg body weight and paracetamol from 7 to 15 mg/kg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants selected a number; an independent person had previously numbered and anonymised containers |
Allocation concealment (selection bias) | Unclear risk | See above. The independent person then allocated drugs in lightproof anonymised containers that contained the premeasured volume. It is unclear how the participants were instructed regarding the time at which they took the solution and also the amount of the solution if they were blind to the drug they were taking. We sent an email to the trial authors for clarification |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" Participant and operator were blind to the intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The trial authors evaluated all included participants |
Selective reporting (reporting bias) | Low risk | The trial authors reported all expected outcomes |
Other bias | Low risk | None apparent |