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

January 13, 2025 updated by: Elif Buse Kaplan, Ondokuz Mayıs University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55200
        • Ondokuz Mayıs University
      • Samsun, Atakum, Turkey, 55200
        • Ondokuz Mayıs Üniversity Facult of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individuals with a daily cigarette consumption of fewer than 10 cigarettes.
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.
Experimental: Individuals who consume between 10 and 20 cigarettes per day
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.
Experimental: Individuals who consume more than 20 cigarettes per day.
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.
Active Comparator: Individuals who do not smoke
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation level
Time Frame: Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.
Oxygen saturation is a parameter that represents the percentage of oxygen bound to hemoglobin molecules in arterial blood. It is a critical physiological indicator that reflects whether sufficient oxygen is being transported to the body's tissues. Normal oxygen saturation levels typically range between 95% and 100%, while levels below this range are referred to as hypoxemia, indicating a deficiency in oxygen supply. Oxygen saturation is commonly measured using a non-invasive method known as pulse oximetry.
Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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