Gazal 2004.
| Methods | Study design: 2‐arm parallel randomised trial Conducted in: UK Number of centres: 1 Setting: dental hospital Recruitment period: unclear Funding source: not reported |
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| Participants | Inclusion criteria: 2 to 12 years of age, 1 to 10 teeth extracted, healthy with no known allergies Exclusion criteria: known allergy to LA or paracetamol, refused preoperative dose paracetamol, too distressed to be included Number of participants randomised: total = 139 (group 1 = 69, group 2 = 70) Number of participants evaluated: total = 135 (group 1 = 68 (36 male, 32 female), group 2 = 67 (33 male, 34 female)) Group 1: mean age (years) = 5.9 (SD 2.16) Group 2: mean age (years) = 5.9 (SD 2.24) Age range = 2 to 12 years |
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| Interventions | Group 1: 0.25% bupivacaine with 1:4000 adrenaline topical (swab) Group 2: saline |
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| Outcomes | Five‐face scale of distress Measured preoperatively, on waking, and at 15 minutes |
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| Notes | GA procedure: induced with propofol, maintained with nitrous oxide/enflurane Co‐interventions: All participants received preoperative paracetamol 15 mg/kg Declarations of interest: none reported There was a sample size calculation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A statistician randomly allocated the sequence of patient identity numbers to either a test or control group using computer generated random numbers" Comment: The paper stated the method of sequence generation |
| Allocation concealment (selection bias) | Low risk | An independent party allocated treatment using numbered, opaque sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patient and the dentist carrying out the assessment were blind as to which group the child had been allocated" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The patient and the dentist carrying out the assessment were blind as to which group the child had been allocated" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The number of dropouts was similar across groups (1/69 in the LA group, 3/70 in the placebo group), but reasons were not given |
| Selective reporting (reporting bias) | Low risk | The study reported all expected outcomes |
| Other bias | Low risk | There was no other apparent bias |