Do Throat Pack Used in Dental Treatments Under General Anesthesia of Patients Have an Effect on PONV and Sore Throat?
NCT ID: NCT06169306
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
74 participants
INTERVENTIONAL
2024-01-01
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The incidence of cavities and other dental problems is higher in special health care needs due to reasons such as inadequate oral hygiene, malocclusion, high-carbohydrate diet, and lack of awareness about dental health. In this group of patients, dental treatments are primarily performed under general anesthesia. Since side effects are more difficult to identify by the patient, the procedures, technical applications and anaesthesia methods should be those with the least potential for side effects. Evidence is needed regarding the effect of throat packing on PONV. In this study, researchers planned to investigate the effects of using throat tampons during dental treatments under general anesthesia on PONV and sore throat in participants requiring special health care.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control
Following endotracheal intubation, no throath pack will inserted into the hypopharynx.
No interventions assigned to this group
throath pack
Following endotracheal intubation, throath pack will inserted into the hypopharynx.
throat pack
Following endotracheal intubation, one saline soaked, throat pack will inserted into the hypopharynx under direct vision. The packs will record in writting on the anaesthesia safety form.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
throat pack
Following endotracheal intubation, one saline soaked, throat pack will inserted into the hypopharynx under direct vision. The packs will record in writting on the anaesthesia safety form.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being between the ages of 5-16
* Being grade 1 or 2 according to the ASA (American Society of Anesthesiologists) classification
* At least one primary or permanent and one restorative. Having undergone treatment (amalgam or composite restoration)
Exclusion Criteria
* Being evaluated as having difficult intubation
* Having an additional disease related to the oesophagus, stomach or intestines, having a percutaneous endoscopic gastrostomy,
* Having a history of PONV,
* Having morbid obesity,
* Having high airway pressure,
* Having a history of allergy to the drugs to be used,
* Needing an anaesthetic agent other than the anaesthesia method to be applied
* Having advanced mental retardation that prevents data collection
5 Years
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cukurova University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sibel Tetiker
Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sibel Tetiker
Role: PRINCIPAL_INVESTIGATOR
Cukurova University Faculty of Dentistry, Pediatric Dentistry
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Tetiker S, Akdogan HN, Alpay N, Dogan MC. Effect of Dental Throat Pack Used Under General Anesthesia in Children with Special Healthcare Needs on Postoperative Nausea, Vomiting, and Sore Throat: A Randomized Clinical Trial. J Clin Med. 2025 Jan 17;14(2):567. doi: 10.3390/jcm14020567.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CUDHF-PABD
Identifier Type: -
Identifier Source: org_study_id