Oral melatonin vs nitrous oxide inhalation for paediatric dental sedation: a randomised controlled ELISA-based study

To 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.

In 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).

Both 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).

Both 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.

The study protocol was registered at https://ctri.nic.in under the identifier CTRI/2023/08/056173.