ArticleEuropean archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry2026
Effect of cryoanaesthesia on pain during intraoral anaesthetic puncture in children: a randomised controlled non-inferiority trial.
Article in European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeEffective pain control during local anaesthetic administration is essential in paediatric dentistry. Although topical anaesthetic gels are widely used, concerns remain about dosage control. Cryoanaesthesia has emerged as a non-pharmacological alternative. This randomised controlled trial aimed to evaluate the non-inferiority of cryoanaesthesia compared with 20% benzocaine gel in reducing self-reported pain during mandibular infiltrative anaesthetic puncture in children.
methodsForty children aged 6 to 9 years, each with at least one mandibular primary molar requiring treatment under local anaesthesia, were included. Participants were randomised to receive either cryoanaesthesia or 20% benzocaine gel as the topical anaesthetic intervention. Self-reported pain was assessed using the Visual Analogue Scale immediately after initial anaesthetic puncture. Pre-operative child and parental anxiety, as well as the child's behaviour during anaesthesia, were also evaluated. A one-sided Student's t-test for non-inferiority was applied to compare mean pain scores between groups. Multiple linear regression was performed to identify potential associations between independent variables and self-reported pain.
resultsThe mean age of the participants was 7.63 ± 1.23 years. Mean self-reported pain scores were 38.50 ± 41.20 in the benzocaine group and 38.00 ± 36.54 in the cryoanaesthesia group. Non-inferiority of cryoanaesthesia was not demonstrated (mean difference: 0.50 ± 4.69, 95% CI -24.42 to 25.42, p = 0.22). A statistically significant association was observed between negative behaviour and self-reported pain (β = 45.21; 95% CI 18.68 to 71.74; p < 0.001).
conclusionThe non-inferiority of cryoanaesthesia compared with 20% benzocaine gel for mandibular topical anaesthesia in children could not be demonstrated. CLINICAL TRIAL REGISTRY: Brazilian Registry of Clinical Trials-REBEC (Identifier: RBR-74w5bt4), available at https://ensaiosclinicos.gov.br/rg/RBR-74w5bt4 , registered on March 12th, 2025.
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