Takmaz 2009.

Study characteristics
Methods	Study design: prospective, randomised, double‐blind, controlled trial Intention‐to‐treat: Not stated Sample size calculation: "The calculated sample size for a clinical difference of 4.5 hours between the groups, at an alpha error of 5% and a beta error of 90%, was 20 per group" Setting: single centre. Turkey Follow up: 24 hours
Participants	N = 40 (65% male)
Interventions	Group 1: (n = 20) extraoral infraorbital nerve block with 1.5 ml of bupivacaine 0.25% with adrenaline Group 2: (n = 20) "sham" block with saline solution
Outcomes	Pain measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale Heart rate, blood pressure, and respiratory rate Time to first analgesic requirement Rescue analgesia requirement Parent satisfaction Adverse effect
Notes	Jadad score: 5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number table
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"In all patients, the nerve block was performed by the anaesthetist who was unaware of the content of the solution"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Postoperative assessment was performed by an investigator blinded to the patient’s group"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No losses
Selective reporting (reporting bias)	Low risk	The report of the study was free of suggestion of selective outcome reporting
Other bias	High risk	Size: sample size less than 50 per treatment arm