Townsend 2009.
| Methods | Study design: 2‐arm parallel randomised trial Conducted in: USA Number of centres: 1 Setting: dental surgery centre, children's hospital Recruitment period: unclear Funding source: not reported |
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| Participants | Inclusion criteria: ASA I to II, speak English, free of developmental delay or psychiatric conditions, minimum of 2 fillings, 2 anterior extraction, and placement of 4 preformed crown with 1 in each arch Exclusion criteria: adverse drug reaction or medical contraindication Number of participants randomised/evaluated: total = 27 (group 1 = 15 (5 female, 10 male), group 2 = 12 (3 female, 9 male)) Group 1 mean age (years) = 4.3 (SD = 0.78) Group 2 mean age (years) = 3.8 (SD = 0.68) Age range = 3 to 5.5 years |
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| Interventions | Group 1: IFL 1 mg/kg ketorolac and 0.3 ml 2% lidocaine with 1:100000 adrenaline infiltration of each tooth treated Group 2: 1 mg/kg ketorolac |
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| Outcomes | FLACC Pain Assessment Tool and Wong‐Baker FACES® Pain Rating Scale Measured at 5 minutes and 4 to 6 hours |
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| Notes | Induction sevoflurane, propofol, or both, maintained with isoflurane/nitrous oxide Co‐interventions: All participants received dexamethasone 0.1 mg/kg and were given a bottle of paracetamol 15 mg/kg at discharge Declarations of interest: none reported There was no sample size calculation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...assigned by a random number generator" Comment: We assumed the sequence generation was computer‐generated |
| Allocation concealment (selection bias) | Unclear risk | There was insufficient information to make a judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The surgeon and anaesthesiologist were not blinded to local anaesthetic administration" Comment: The study blinded participants, but not personnel performing the extractions |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The nurse, who was blinded to local anesthetic status, evaluated the patient at 5‐minute intervals" "Parents were also blinded as to local anesthetic administration" Comment: The study blinded the assessor |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were accounted for at follow up prior to discharge; outcome measures for 20/27 children at follow up at home; loss to follow up was similar across groups |
| Selective reporting (reporting bias) | Low risk | The study recorded all expected outcomes |
| Other bias | Low risk | There was no other apparent bias |