Passive Smoking Effects on Sedation in Children Undergoing Tooth Extraction
Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking
+ Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking
Diagnostic Study
Summary
Study start date: April 1, 2024
Actual date on which the first participant was enrolled.This study is focused on understanding the impact of passive smoking on children aged 4 to 6 years who are undergoing tooth extractions with sedation. The research aims to evaluate how exposure to secondhand smoke affects vital signs, levels of movement, and agitation during and after dental procedures. By involving 100 children, the study is designed to compare those exposed to passive smoking with those who are not, helping to reveal any differences in sedation outcomes and recovery. This research is important because it seeks to improve the understanding of how environmental factors like passive smoking can affect children's health and recovery during dental procedures. During the study, participants undergo tooth extractions while being sedated, with their vital signs closely monitored throughout the procedure. Parents or guardians fill out a questionnaire to assess the child's exposure to passive smoking. The study uses various assessment tools, including the Richmond Agitation-Sedation Scale to measure agitation, the Modified Aldrete Score to evaluate recovery time, and the Pediatric Anesthesia Emergence Delirium Scale to assess behavior as the child wakes up. These measurements help to determine the influence of passive smoking on sedation effectiveness and recovery, potentially highlighting risks associated with secondhand smoke exposure in children during medical treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 4 to 6 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Ondokuz Mayıs Üniversity Facult of Dentistry
Samsun, Turkey (Türkiye)