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 |
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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 |
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Interventions | Group 1: IFL, 0.5 ml 2% lignocaine with 1:80,000 adrenaline infiltration per quadrant Group 2: NLA |
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Outcomes | TPPPS and assessment of bleeding through total blood loss per root Measured at 1 minute, 5 to 6 minutes, and 11 minutes postoperatively |
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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" |
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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" |