Assessing the Brain Activity of Oral Sedation versus Nitrous Oxide Sedation in Paediatric Patients: A Randomised, Cross-over, Clinical Trial
TL;DR
Both the groups resulted in acceptable, efficient and safe outcomes with no much difference in the brain activity levels, according to the findings of the present study.
Abstract
Introduction: Managing Dental Fear and Anxiety (DFA) using pharmacological approaches including oral and Nitrous Oxide (N2 O) sedation techniques is a major challenge in paediatric dentistry. Although management of DFA using pharmacological approaches is considered safe, it is necessary to monitor vital indicators like Oxygen Saturation (SpO2 ) and pulse rate levels to avoid unpredictable adverse events. Aim: To compare and evaluate the differences in brain activity patterns, monitoring of pulse rate and SpO2 levels during oral sedation and N2 O sedation in paediatric patients undergoing pulp therapy for primary mandibular molars. Materials and Methods: The present randomised, cross-over, clinical trial study was conducted in the Department of Paediatrics and Preventive Dentistry, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Deemed University, Karad, Maharashtra, India during the period of August 2023 to October 2025. A total of 14 (N=14) primary mandibular molars indicated for pulp therapy were included in the study. Midazolam oral sedation was administered to one primary molar at first visit (Group A) and N2 O inhalation was administered to another primary molar (Group B) in the same participant in the second visit in a cross over manner. Vital indicators, including SpO2 and pulse rate were tracked at three different intervals (baseline, mid-treatment, after withdrawal of the drug). Clark’s formula was applied for oral sedation and patient’s flow rate was checked for N2 O sedation. Electroencephalogram (EEG) was used for interpretation. Statistical Package for Social Sciences (SPSS) statistical software (version 25; IBM, Armonk, NY, USA) was used to statistically analyse the data. Tukey’s post-hoc and Chi-square test were used to compare mean and categorical variables. Results: The mean pulse rate values obtained with oral sedation vs N2 O sedation at baseline, mid-treatment and post-treatment were 85.8±0.6; 85.7±0.5; 85.2±0.5(p=0.720) vs 85.8±0.6; 85.6±0.5; 85.3±0.5 (p=1.000; p=0.728; p=0.720), respectively. The mean SpO2 levels with oral sedation vs N2 O sedation at baseline, mid-treatment and post-treatment were 97.7±0.02; 96.8±0.19; 97.07±0.17 vs 97.78±0.22; 97.2±0.19; 97.1±0.14, respectively (p=1.000; p<0.001; p=0.392). However, the intergroup differences were not statistically significant (midtreatment vs post-treatment) (p=0.142 vs p=0.506) and the EEG displayed no notable deviations, indicating that there had been no appreciable changes in brain activity in both the groups. Conclusion: According to the findings of the present study, both the groups resulted in acceptable, efficient and safe outcomes with no much difference in the brain activity levels.
