NCT06780189

The Effects of Passive Smoking on Vital Signs, Anxiety, and Recovery Times in Children Undergoing Primary Tooth Extraction Treatment Under Sedation

Investigation of the Effects of Passive Smoking on Vital Signs, Motor Activity Levels, and Agitation Severity in Children Undergoing Tooth Extraction With Sedation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study is to evaluate the effects of passive smoking on the vital parameters of children undergoing primary tooth extraction under sedation and to assess their anxiety levels throughout the process until discharge. The main questions it aims to answer are: 1. Do the vital parameters of children who are passive smokers differ from those of non-passive smokers under sedation? 2. Does the amount of smoking by family members influence the child's vital parameters? 3. Does passive smoking affect recovery and awakening times following sedation? 4. Does passive smoking impact the anxiety levels of children during the period leading up to discharge? Participans: * Children aged between 4 and 6 years, * Children with an ASA score of 1, * Children with a Frankl score of 4, 5, or 6, * Children with an indication for primary tooth extraction, * Parents/guardians who do not use electronic cigarettes.

Detailed description

Sample Size Calculation and Study Design The sample size for this study was calculated based on the article by A.C. Torun et al. (1), titled "Sedative - Analgesic Activity of Remifentanil and Effect of Preoperative Anxiety on Perceived Pain in Outpatient Mandibular Third Molar Surgery." According to this reference, the minimum required sample size was determined to be 64, with a 95% confidence interval and 5% sensitivity. A total of 100 children were included in the study, of whom 36 were classified as non-passive smokers and 64 as passive smokers. Inclusion Criteria Participants included in the study must meet the following criteria: * Children aged between 4 and 6 years, * Children with an ASA physical status classification of 1, * Children scoring 1 or 2 on the Frankl Behavior Scale, * Children with an indication for primary tooth extraction. Evaluation Parameters 1. Assessment of Passive Smoking: Before the sedation procedure, parents/guardians will complete a questionnaire to determine the child's exposure to passive smoking. 2. Monitoring of Vital Parameters: During the sedation procedure, all patients will be connected to a monitoring device to record their vital parameters. 3. Assessment During and After Sedation: * Richmond Agitation-Sedation Scale (RASS): This scale will be applied during the sedation procedure and for 5 minutes after the procedure is completed. * Modified Aldrete Score (MASS): This scale will be used to measure recovery time. * Pediatric Anesthesia Emergence Delirium (PAED) Scale: Starting from the moment the patient regains consciousness, scores will be recorded every 5 minutes. Outcome Measurement The data obtained from the questionnaires, monitoring devices, and applied scales will be analyzed to evaluate the effects of passive smoking on sedation outcomes, recovery times, and emergence behaviors. All measurements will be conducted with consistency and reliability.

Conditions

• Dental Sedation
• Passive Smoking

Interventions

Type	Name	Description
PROCEDURE	Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking	This study is designed to evaluate the relationship between passive smoking and the vital parameters of children undergoing deep sedation. Additionally, the study aims to comprehensively assess and document the entire treatment process from start to finish by using the RASS, MASS, and PAED scales for postoperative evaluation.
PROCEDURE	Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking	This study is designed to measure the differences in vital parameters of children undergoing deep sedation who are not exposed to passive cigarette smoke at home. Furthermore, the study aims to comprehensively evaluate and document the entire treatment process from start to finish using the RASS, MASS, and PAED scales for postoperative assessment.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

2 sites across 1 country: Turkey (Türkiye)