Noble 1994.
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: 3 to 14 years of age having 1 or more teeth extracted Exclusion criteria: failure to obtain consent and abscess formation Number of participants randomised/evaluated: total = 100 (group 1 = 57 (28 male, 29 female), group 2 = 43 (27 male, 16 female)) Group 1: mean age (years) = 7.1 (SEM = 0.7) Group 2: mean age (years) = 6.5 (SEM = 0.5) |
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Interventions | Group 1: IFL 3% prilocaine with 0.03 U/ml felypressin infiltration Group 2: NLA |
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Outcomes | Distress scale Measured at 5 minutes and 30 minutes Visual assessment scale (VAS) measured at 30 minutes |
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Notes | Induction intravenously with methohexital or inhalation with halothane/nitrous oxide. Maintained with halothane/nitrous oxide Co‐interventions: Children who remained distressed were offered oral acetaminophen oral suspension before 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: "...were allocated randomly, by the toss of a coin..." Comment: The paper stated the method of sequence generation |
Allocation concealment (selection bias) | Unclear risk | The paper did not provide information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The study blinded participants. It was unclear whether the study blinded personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Postoperative assessments for each patient were performed by one of two anaesthesiologists who was unaware of the child's treatment group" Quote: "Global assessment of distress by a blinded observer..." Comment: The study blinded the assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The outcome evaluation included all participants |
Selective reporting (reporting bias) | Low risk | The study reported all expected outcomes |
Other bias | Unclear risk | There were more males than females in the no‐LA group (27 males versus 16 females in the no‐LA group, 28 versus 29 in the GA with LA group) |