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. 2014 Dec 23;2014(12):CD009742. doi: 10.1002/14651858.CD009742.pub2

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
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)
Interventions Group 1: IFL 3% prilocaine with 0.03 U/ml felypressin infiltration
Group 2: NLA
Outcomes Distress scale
Measured at 5 minutes and 30 minutes
Visual assessment scale (VAS) measured at 30 minutes
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
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)