Clinical trial NCT06169306: Do Throat Pack Used in Dental Treatments Under General Anesthesia of Patients Have an Effect on PONV and Sore Throat?
Official title: Do Throat Packs Used in Dental Treatments Under General anesthesıa of Patients With Special Health Care Needs Have an Effect on Ponv and Throat Pain?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Sore-throat
Dental Caries
Keywords: PONV
sore throath
throath pack
special health care needs
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of throat packs on PONV in dental treatments under general anesthesia in special health care needs.

Detailed description: Throat packs are widely used to prevent aspiration of blood and other debris, especially in orofacial surgeries and dental treatments performed under general anesthesia. Aspiration of blood and other secretions into the stomach is one of the important causes of PONV. There is not much evidence that throat packs prevent nausea and vomiting after surgery. The most critical side effects of throat pack application are sore throat, difficulty swallowing, and being forgotten before extubation.

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.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study with parental consent
* 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:

* Having a tracheostomy
* 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

Primary outcomes:
measure: PONV
timeFrame: 1, 2 and 6 hours
Secondary outcomes:
measure: sore throat
timeFrame: 1, 2 and 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Cukurova University Faculty of Dentistry, Pediatric Dentistry
name: Sibel Tetiker
role: PRINCIPAL_INVESTIGATOR
References: