Nicodemus 1991.

Study characteristics
Methods	Study design: prospective, randomised, double‐blind, controlled trial Intention‐to‐treat: not stated Sample size calculation: not stated Setting: single centre. USA Follow up: 24 hours
Participants	N = 60 (60% male) Age: 2 to 13 years
Interventions	Group 1: (n = 30) intraoral infraorbital nerve block with 1 to 1.5 ml bupivacaine 0.5% plus adrenaline Group 2: (n = 30) saline placebo in the infraorbital area
Outcomes	Pain reported by the children through visual analogue scale (0 to 5) Pain evaluated by nurses and parents through score (0 to 4) Length of analgesia Supplemental analgesic requirements
Notes	Jadad score: 4
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The anaesthetist who performed the block and the subsequent evaluation, the nurses and the parents who evaluated the patient's comfort were all kept unaware of the identity of the solution used for block"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	See above
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