Sep 2026· Journal of Clinical and Diagnostic Research· 0 citations
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.
Nitrous oxide–oxygen inhalation sedation (NOIS) is the recommended first line pharmacological approach for managing dental anxiety in children. Music, owing to its psychoacoustic qualities and autonomic nervous system-influencing potential, emerges as a potential non-pharmacological agent in the management of dental anxiety. The aim of this study was to assess the efficacy of Indian instrumental music as an adjunct to nitrous oxide-oxygen Inhalation sedation. This prospective, three arm parallel- group randomized clinical trial was conducted at the Department of Pediatric and Preventive Dentistry, Yenepoya Dental College, Mangalore (CTRI/2024/04/065857). A total of 39 anxious child participants between the ages of 9 and 12 years (Mean age = 10.56 ± 1.14 years) who required restorative procedures under NOIS, as assessed by MCDASf were included in the study. They were equally distributed among the groups, i.e., Group A (Control Group), Group B (NOIS music through ambient speakers), and Group C (NOIS with music through earphones), each consisting of 13 participants. The intervention used was ‘Minuet in D major' from the album ‘Classicool' performed by sitar maestro Purbayan Chatterjee. Physiological responses such as systolic BP, diastolic BP, and pulse rate PR) were recorded. The earphone group (Group C) showed statistically significant change over time for all physiological parameters. p = 0.003, p = 0.011, p = 0.030, respectively, for systolic bp, diastolic bp, and PR. Intergroup comparisons revealed no statistically significant differences at baseline or post-intervention. A statistically significant between-group difference was noted during the intervention phase exclusively for PR (p = 0.014). The music intervention demonstrated high overall acceptability; 88.5% of participants reported liking the music and 84.6% indicated a desire for its continuation in future appointments (p = 1.000). The use of Indian instrumental music as an adjunct to NOIS in Earphone-delivered music demonstrated statistically significant within-group reductions in all physiological parameters, with a significant intergroup difference in pulse rate during intervention (p = 0.014). Most intergroup differences were non-significant, and these findings should be interpreted as clinically promising trends warranting larger randomized trials rather than definitive evidence of efficacy. Clinical Trial Registration CTRI/2024/04/065857, https://ctri.nic.in/Clinicaltrials/searchbyctri.php
Bharati Honnekeri, S. Hegde K, S. Sargod et al.· Frontiers in Dental Medicine· 0 citations
Selecting an optimal sedation technique is pivotal for balancing efficacy and safety in outpatient dental surgery. Nitrous oxide inhalation and intravenous sedation are widely used, yet comprehensive comparative data in similar clinical environments are needed to guide practice. The objective of this study was to prospectively compare the clinical efficacy, safety, and recovery profiles of nitrous oxide inhalation sedation versus intravenous midazolam sedation for outpatient dental surgical procedures. This prospective cohort study was conducted at Liberty Hospital Ltd. Paribagh, Shahbagh, Dhaka, Bangladesh, from January to December 2024. A purposive sample of 50 patients was allocated to receive either nitrous oxide/oxygen (n=25) or intravenous midazolam sedation (n=25). Efficacy was measured by procedure completion, operator satisfaction (10-point VAS), and patient-reported anxiety reduction. Safety outcomes included hemodynamic stability, adverse event incidence, and time to meet a modified Aldrete recovery score of ≥9. Data were analyzed using SPSS version 23.0. Both techniques achieved 100% procedure completion. Intravenous sedation provided superior operator satisfaction and greater anxiety reduction (p<0.001). However, nitrous oxide yielded a significantly faster recovery time (8.5 vs. 33.1 minutes, p<0.001) and lower rates of postoperative nausea (8.0% vs. 36.0%, p=0.021) and hypotension (4.0% vs. 32.0%, p=0.019). Hemodynamic changes were more pronounced with IV sedation. Intravenous sedation is optimal for profound anxiolysis in complex cases, while nitrous oxide is ideal for routine procedures, prioritizing rapid recovery and fewer side effects. The choice should be individualized based on patient factors and procedural demands.
CBMJ 2026 July: Vol. 15 No. 02 P:283-289
M. Nahar, Md Toufiqur Rahman, Mohammad Ataul Hasan et al.· Community Based Medical Jour...· 0 citations
Background Several research studies reported the anxiolytic and analgesic properties of nitrous oxide sedation, as well as its effectiveness in facilitating dental procedures for anxious populations, specifically, dental patients with high blood pressure. Objective This clinical observational study aims to assess the impact of inhalation sedation using nitrous oxide mixed with oxygen on cardiovascular haemodynamics in hypertensive patients requiring dental treatment. Methods and Materials Adult dental patients with hypertension and dental anxiety who attended the dental clinic with acute dental pain were included in the study. Non-invasive blood pressure (NIBP/mmHg), heart rate (beats per min (bpm)), and oxygen saturation (SPO2%) were measured before, during, and after inhalation sedation. Participants’ dental anxiety and need for conscious sedation were measured using the Modified Dental Anxiety Scale and the Indicator of Sedation Need, respectively. Dental procedure characteristics and sedation details were also collected, such as procedure type and duration, number of visits, and nitrous oxide concentration. Results Significant reductions in heart rate and blood pressure were observed during and after the procedure compared with baseline. Mean heart rate decreased from pre-sedation to intraprocedural and post-procedural phases, while blood pressure shifted from pre-hypertensive or hypertensive levels to normal in most participants during and after sedation. Respiratory rate remained stable, and oxygen saturation was maintained at optimal levels throughout all phases. Conclusion Inhalation sedation with nitrous oxide and oxygen was associated with reductions in heart rate and blood pressure in hypertensive patients undergoing dental treatment, while maintaining stable oxygen saturation. It was also associated with reduced dental anxiety and facilitation of dental procedures. These findings suggest a potentially beneficial role for inhalation sedation in this population; however, causal inferences are limited by the observational study design.
H. Abed· Oral Health & Preventive Den...· 0 citations
Highlights What are the main findings? Outpatient conscious sedation with titrated nitrous oxide/oxygen, alone or combined with midazolam, enabled the successful completion of all planned complex dental and minor oral surgical procedures in selected uncooperative pediatric and special needs patients. No procedure required conversion to deep intravenous sedation or general anesthesia, and no major adverse events or airway emergencies were observed. What are the implications of the main findings? Appropriate patient selection, behavioral management and clinician expertise may allow complex pediatric dental procedures to be completed under conscious sedation in selected patients. Dedicated outpatient Conscious Sedation Units may provide an additional treatment pathway for selected pediatric patients; however, their effect on access to care, hospital-resource utilization, and costs requires dedicated comparative evaluation. Abstract Aim: This two-center retrospective observational study evaluated whether outpatient conscious sedation protocols based on titrated nitrous oxide/oxygen, midazolam, or their combination enabled complex dental and minor oral surgical procedures to be completed in uncooperative pediatric and special needs patients, without escalation to deep intravenous sedation or general anesthesia. Materials and Methods: Forty pediatric and special needs patients treated at the Conscious Sedation Units of Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (Milan, Italy) and Policlinico of Bari (Bari, Italy) were included. Overall, 60 complex dental or minor oral surgical procedures were performed. Procedures were classified according to the sedation protocol administered: Protocol A, nitrous oxide/oxygen inhalation sedation alone; Protocol B, midazolam alone; and Protocol C, combined midazolam and nitrous oxide/oxygen sedation. Vital signs were monitored before, during, and after treatment. The primary outcome was successful procedural completion, defined as completion of the planned procedure without premature termination, escalation to deep intravenous sedation or general anesthesia, or the need for unplanned airway or emergency medical intervention. Results: Forty patients underwent 60 procedures. The mean age was 8.7 ± 2.3 years (range, 4–14 years). Protocol A was used in 24 procedures (40%), Protocol B in 6 procedures (10%), and Protocol C in 30 procedures (50%). All procedures were completed successfully, with no conversion to general anesthesia, no airway crises, and no medical emergencies. Transient elevations in heart rate and blood pressure during local anesthesia occurred in 11/60 procedures (18.3%), and mild self-limiting nausea or fatigue occurred in 5/60 procedures (8.3%). Conclusions: The evaluated protocols were associated with successful procedural completion and few recorded adverse events in this selected cohort. Combined behavioral and pharmacological management was associated with completion of the planned procedures without conversion to deep intravenous sedation or general anesthesia. Comparative studies are required to determine whether these protocols reduce general-anesthesia utilization.
Lucia Giannini, N. Cenzato, G. Menozzi et al.· Children· 0 citations
Introduction: Local Anaesthetic (LA) solutions often incorporate vasoconstrictors to delay the systemic absorption of the drug. This prolongs the duration of anaesthesia, reduces toxicity by slowing systemic uptake, lowers the total required dose of LA and enhances anaesthetic efficacy by localising the drug at the injection site. Despite extensive published literature, the systemic metabolic effects of these agents in diabetic dental patients remain underexplored.
Aim: To evaluate the effect of local anaesthesia with and without adrenaline on blood glucose levels and haemodynamic parameters in patients undergoing routine tooth extractions.
Materials and Methods: This prospective study was conducted at the Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth Dental College, and Hospital, Sangli, Maharashtra, India, from January 2017 to December 2019. The study included 120 patients aged 17 to 65 years requiring multiple tooth extractions, comprising both medically stable non-diabetic individuals and patients with controlled Type 2 Diabetes Mellitus (T2DM) as the primary inclusion criteria. Each participant received two anaesthetic regimens in separate appointments in randomised order. Haemodynamic parameters (systolic and diastolic blood pressure, heart rate) and random blood glucose levels were recorded before injection (R0), immediately after (R1), and at 10 (R2) and 20 minutes (R3) post-injection. Data were analysed using repeated-measures Analysis of Variance (ANOVA) with Bonferroni post-hoc tests for intragroup comparisons, Independent t-tests for intergroup change scores, and Chi-square tests for categorical variables (p≤0.05).
Results: Lignocaine with adrenaline produced significant transient increases in systolic blood pressure, heart rate, and blood glucose levels in diabetic subjects compared with plain lignocaine (p<0.001). Non diabetic patients exhibited smaller, but statistically significant increases in haemodynamic parameters with adrenaline (p<0.05). Blood glucose changes were also statistically significant with adrenaline in non diabetic patients as well (+11.8 mg/dL, p<0.001), although less pronounced than in diabetic subjects. Diastolic blood pressure showed statistically significant but clinically modest increases with adrenaline in both groups (p<0.001), whereas plain lignocaine produced minimal diastolic pressure.
Conclusion: LA solutions can elicit systemic metabolic responses, and caution is warranted when using lignocaine containing adrenaline in patients with T2DM patients. Clinicians should consider plain LA alternatives for diabetic patients when prolonged anaesthesia or enhanced haemostasis is not essential. Patient specific risk assessment is recommended preoperatively, particularly for those with suboptimal glycaemic control despite HbA1c ≤7%. Future studies should evaluate longer term impact on glycaemic control and incorporate non invasive cardiac output monitoring.
Harshawardhan Kadam, CV Pattanshetti, Swapnil U. Shinde et al.· Journal of Clinical and Diag...· 0 citations
OBJECTIVES
To assess the efficacy and safety of intravenous remimazolam besylate for sedation during dental procedures in patients with cognitive disabilities, a group frequently managed under general anesthesia due to poor cooperation and increased perioperative risks.
MATERIALS AND METHODS
In this single-center prospective single-arm observational study, 43 adult patients with cognitive or motor disabilities (ASA II-III) received outpatient dental care under intravenous remimazolam. Sedation was titrated to moderate levels according to EMA and IACSD guidelines. Outcomes included procedural success, Ramsay Sedation Scale, Post-Anesthetic Discharge Scoring System (PADSS), Modified Aldrete Score (MAS), vital signs, drug dosage, recovery, adverse events, and caregiver feedback.
RESULTS
All treatments were successfully completed without anesthesiologist intervention or flumazenil reversal. Mean onset of sedation was 3.8 ± 2.3 min, recovery time 47 ± 20.4 min, and time to discharge 72.5 ± 22.5 min. The mean total remimazolam dose was 14 ± 5.9 mg. Most patients reached Ramsay 4, while 9.7% remained ≤ 3. Vital parameters remained stable with no episodes of hypoxemia or airway compromise. At discharge, PADSS averaged 8.9 ± 1.0 and MAS 9.4 ± 0.6, confirming recovery despite motor or neurological limitations affecting PADSS scoring. Caregiver interviews indicated that 42% of patients slept during the day, 85% slept normally at night, 68% appeared calmer, and only 7% experienced minor adverse effects such as nausea or brief agitation.
CONCLUSIONS
Remimazolam provided safe and effective intravenous sedation with rapid onset and reliable recovery. Combining PADSS with MAS improved discharge assessment in this patient population.
CLINICAL RELEVANCE
Remimazolam deserves further investigation as a potential practical alternative to general anesthesia for dental procedures in patients with cognitive disabilities, with the potential to enable safe care, procedural success, and favorable recovery profiles.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number (ISRCTN) registry, ISRCTN39322806. Retrospectively registered on 10 November 2025.
G. Grossi, G. Menozzi, Matteo Pellegrini et al.· BMC Oral Health· 0 citations
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