Trial reportEuropean archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry2026
Oral melatonin vs nitrous oxide inhalation for paediatric dental sedation: a randomised controlled ELISA-based study.
Trial report 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
aimTo evaluate and compare the sedative, anxiolytic, and post-operative effects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8-year-olds for reducing dental anxiety in children. MATERIALS AND
methodsIn this randomised clinical trial, 78 cooperative children were allocated to three groups: Tell-Show-Do (control), N₂O inhalation sedation, and oral melatonin sedation. Anxiety was assessed using Venham's Anxiety Scale, pulse rate, oxygen saturation (SpO₂), and salivary cortisol using Enzyme-Linked Immunosorbent Assay (ELISA). Sedation was evaluated with the Houpt Sedation Rating Scale, and post-operative effects and parental satisfaction were recorded after 24 h. Data were analysed using one-way ANOVA and paired t-tests, with within-group changes expressed as Cohen's d effect sizes and 95% confidence intervals (CI).
resultsBoth N₂O and melatonin groups showed significant reductions in Venham's Anxiety Scores compared with the control group (p < 0.001, d = 0.82 [95% CI: 0.61-1.02] for N₂O; p = 0.002, d = 0.68 [95% CI: 0.47-0.89] for melatonin). Face, Legs, Activity, Cry, Consolability (FLACC) pain scores decreased substantially in both sedation groups (p < 0.001, d = 1.57 for N₂O; d = 3.68 for melatonin), indicating strong analgesic and behavioural control. Salivary cortisol levels also decreased significantly in the N₂O (p < 0.001, d = 0.91 [95% CI: 0.70-1.12]) and melatonin groups (p < 0.001, d = 0.74 [95% CI: 0.54-0.94]), whilst changes in the control group were nonsignificant (p = 0.48). Pulse rate declined significantly in both sedation groups (p < 0.001), whereas SpO₂ remained stable across all groups. No significant difference was found between N₂O and melatonin in sedation efficacy (p = 0.28) or post-operative recovery (p = 0.31).
conclusionBoth nitrous oxide inhalation sedation and oral melatonin effectively reduced anxiety and pain, with melatonin emerging as a potential alternative to nitrous oxide for paediatric dental procedures. CLINICAL TRIAL: The study protocol was registered at https://ctri.nic.in under the identifier CTRI/2023/08/056173.
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