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

Al‐Bahlani 2001.

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: unclear; medically fit and well
Exclusion criteria: not reported
Number of participants randomised/evaluated: total = 100 (group 1 = 50, group 2 = 50)
Age range = 3 to 5 years
Interventions Group 1: IFL, 0.5 ml 2% lignocaine with 1:80,000 adrenaline infiltration per quadrant
Group 2: NLA
Outcomes TPPPS and assessment of bleeding through total blood loss per root
Measured at 1 minute, 5 to 6 minutes, and 11 minutes postoperatively
Notes Co‐interventions: none reported
Declarations of interest: none reported
There was no sample size calculation
The observation period for the TPPPS was reduced from the validated period of 30 minutes to 11 minutes: "no greater discrimination between groups could be determined after this period of observation"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly allocated"
Comment: The paper did not describe the method of sequence generation
Allocation concealment (selection bias) Unclear risk The paper did not describe the method of allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Explanation was made to the child of the sensations to be expected postoperatively either with or without local analgesia"
Comment: The study did not blind participants. It was unclear whether personnel were blinded as the comparator was no treatment
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessment was blinded; however, the study did not blind participants, and this may well have influenced how they behaved postoperatively
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 outcomes, but it was not clear whether the single summary distress scores presented were averaged over all 3 periods of measurement or reported for a single (unspecified) time point
Other bias High risk The authors reduced the observation period for TPPPS from the validated period of 30 minutes to 11 minutes as "no greater discrimination between groups could be determined after this period of observation"