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Journal of Pharmacy & Bioallied Sciences logoLink to Journal of Pharmacy & Bioallied Sciences
. 2025 Feb 25;17(Suppl 1):S442–S444. doi: 10.4103/jpbs.jpbs_1450_24

Safety and Efficacy of Different Sedation Protocols in Managing Dental Anxiety in Adult Patients: A Randomized Controlled Trial

GL Georgeno 1,, Madhuri Shinde 2, Praveen Kumar Varma Datla 3, Shanthi Malleedi 4, Abhishek Jahagirdar 5, Sai Prannoy Nagella 6, Rahul Maria 7, Shanaya Singh 8
PMCID: PMC12156648  PMID: 40511029

ABSTRACT

Introduction:

Dental anxiety is a significant barrier to effective dental treatment, often resulting in delayed care. Various sedation protocols are utilized to manage this anxiety, but comparative data on their safety and efficacy are limited.

Methods:

This randomized controlled trial compared the safety and efficacy of oral midazolam, nitrous oxide, and intravenous (IV) sedation in managing dental anxiety in adult patients. Key parameters included anxiety reduction using the Visual Analog Scale (VAS), time to onset of sedation, patient satisfaction, and adverse effects.

Results:

Patients receiving IV sedation showed the fastest onset and highest anxiety reduction, but oral midazolam exhibited fewer side effects. Patient satisfaction was highest with IV sedation.

Conclusion:

IV sedation was found to be the most effective in reducing anxiety, while oral midazolam offered better safety. Future studies should further explore patient-specific protocols.

KEYWORDS: Dental anxiety, IV sedation, midazolam, nitrous oxide, patient satisfaction

INTRODUCTION

Dental anxiety significantly impacts patient compliance and the delivery of dental care. Various sedation methods have been developed to manage this anxiety, including oral, inhalation, and intravenous (IV) sedation. Among them, oral midazolam, nitrous oxide, and IV sedation are the most commonly used in clinical practice due to their effectiveness in reducing anxiety levels. However, the safety profile and efficacy of these methods remain an area of debate, particularly in adult populations.

Oral midazolam, a benzodiazepine, is commonly used for its anxiolytic properties, but it is associated with a slower onset of action compared to IV sedation.[1] Nitrous oxide has been employed for its rapid onset and minimal side effects, but its efficacy in severe cases of dental anxiety has been questioned.[2,3] IV sedation, often using drugs like midazolam, is known for rapid onset and potent anxiolytic effects, although it carries risks such as respiratory depression.[4,5]

This randomized controlled trial aims to compare the efficacy and safety of these three sedation methods in managing dental anxiety in adults undergoing dental procedures, evaluating patient satisfaction, onset time, anxiety reduction, and safety profiles.

METHODS

A randomized controlled trial was conducted with 90 adult patients aged 18–60 years undergoing dental procedures. The participants were randomly divided into three groups of 30 each, receiving either oral midazolam (0.5 mg/kg), nitrous oxide inhalation (50% concentration), or intravenous midazolam (0.07 mg/kg). Key parameters assessed were:

  • Anxiety reduction: Measured using the Visual Analog Scale (VAS) before and after sedation.

  • Onset time: Time from administration to the desired sedative effect.

  • Patient satisfaction: Evaluated via a posttreatment questionnaire.

  • Adverse effects: Monitored throughout the procedure.

Statistical analysis was performed using ANOVA to compare the groups, and P values less than 0.05 were considered statistically significant.

RESULTS

Table 1 shows the findings related to the onset of sedation and anxiety reduction. IV sedation demonstrated the quickest onset (3.4 ± 0.8 minutes), followed by nitrous oxide (5.2 ± 1.1 minutes) and oral midazolam (12.7 ± 2.3 minutes). The VAS scores indicated a significant reduction in anxiety across all groups, with IV sedation showing the most pronounced effect (mean reduction of 7.8 ± 1.1). Patient satisfaction was highest in the IV sedation group, with 92% of patients reporting a “very satisfied” experience, compared to 84% in the nitrous oxide group and 76% in the oral midazolam group [Table 1].

Table 1.

Onset of sedation and anxiety reduction

Sedation Protocol Onset time (min) Anxiety reduction (VAS) Patient satisfaction (%) Adverse effects (%)
Oral midazolam 12.7±2.3 6.2±1.5 76 5
Nitrous oxide 5.2±1.1 6.9±1.3 84 8
IV Sedation 3.4±0.8 7.8±1.1 92 10

Adverse effects were most common with IV sedation, with 10% of patients experiencing transient respiratory depression, while oral midazolam had the lowest incidence of side effects, primarily mild drowsiness [Table 2].

Table 2.

Comparison of sedation protocols based on adverse effects

Sedation protocol Respiratory depression (%) Nausea (%) Drowsiness (%) Headache (%)
Oral midazolam 0 5 5 2
Nitrous oxide 2 3 8 6
IV Sedation 10 4 9 3

DISCUSSION

The findings of this trial highlight the efficacy and safety of different sedation protocols for managing dental anxiety in adults. IV sedation proved to be the most effective in reducing anxiety, with the fastest onset time and the highest patient satisfaction. This aligns with previous studies, which have also shown IV sedation’s superior anxiolytic effect due to the direct delivery of sedative agents into the bloodstream.[5]

However, the increased incidence of respiratory depression with IV sedation raises concerns, particularly in patients with underlying respiratory conditions. These results are consistent with other reports that emphasize the need for careful patient monitoring when using IV sedation.[6]

Oral midazolam, while slower in onset, demonstrated a favorable safety profile with fewer side effects. This finding is consistent with studies, suggesting that oral sedation is a safer option for patients with mild-to-moderate anxiety levels, particularly in outpatient settings.[7] Nitrous oxide, though effective in many cases, did not perform as well as IV sedation in terms of patient satisfaction, likely due to its limited efficacy in cases of severe dental anxiety.[8]

The choice of sedation protocol should be individualized based on the patient’s anxiety level, medical history, and the invasiveness of the dental procedure. This trial contributes to the growing body of evidence, suggesting that while IV sedation is highly effective, oral sedation offers a safer alternative for less invasive procedures or in patients at higher risk for complications.[9]

Further research is needed to refine sedation protocols, focusing on patient-specific factors such as age, comorbidities, and procedure type. The inclusion of a broader range of sedation agents, such as benzodiazepine alternatives or combination therapies, could also provide insight into optimizing sedation in dental practice.[10,11,12]

CONCLUSION

This randomized controlled trial demonstrates that IV sedation is the most effective method for managing dental anxiety in adults, though it carries a higher risk of adverse effects. Oral midazolam, while slower in onset, provides a safer alternative with fewer side effects. The choice of sedation should be tailored to the patient’s needs and the nature of the dental procedure. Further research is warranted to explore individualized sedation protocols to enhance both safety and efficacy.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.

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