Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single‐blind, combined split‐mouth and parallel‐arm randomized controlled trial

BACKGROUND: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies. AIM: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children. DESIGN: We used an innovative design consisting in simultaneously conducting a multicentre split-mouth and parallel-arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0-10 cm) concerning the insertion of the needle and injection. RESULTS: A total of 30 children were included in the split-mouth RCT and 128 in the parallel-arm RCT. We combined treatment effect estimates by using an inverse-variance weighting meta-analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference -0.69 cm, 95% confidence intervals -1.13 to -0.25 cm). For each patient enrolled in the split-mouth RCT, about five were enrolled in the parallel-arm RCT, which allowed for not losing any eligible patients. CONCLUSION: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433).