Clinical trial NCT06780189: The Effects of Passive Smoking on Vital Signs, Anxiety, and Recovery Times in Children Undergoing Primary Tooth Extraction Treatment Under Sedation
Official title: Investigation of the Effects of Passive Smoking on Vital Signs, Motor Activity Levels, and Agitation Severity in Children Undergoing Tooth Extraction With Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Sedation
Passive Smoking
Keywords: primary tooth
passive smoking
Tooth extraction
dental sedation
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children aged between 4 and 6 years,
* Children classified as ASA 1,
* Children scoring 1 or 2 on the Frankl Behavior Scale,
* Children who are uncooperative for tooth extraction in the pediatric dentistry clinic,
* Children with an indication for primary tooth extraction,
* Parents/guardians of Turkish origin,
* Families who provide consent to participate in the study.

Exclusion Criteria:

* Children classified as ASA 2,3, 4, 5, or 6,
* Children scoring 3 or 4 on the Frankl Behavior Scale,
* Children younger than 4 years or older than 6 years,
* Children with acute apical abscess or cyst in the tooth scheduled for extraction,
* Children with an indication for permanent tooth extraction,
* Parents/guardians who use electronic cigarettes,
* Parents/guardians undergoing nicotine replacement therapy,
* Parents/guardians who are not of Turkish origin,
* Families who do not wish to participate in the study.

Primary outcomes:
measure: Oxygen saturation level
timeFrame: Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
state: Atakum
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversity Facult of Dentistry
state: Atakum
Study officials:
References: