Do Throat Pack Used in Dental Treatments Under General Anesthesia of Patients Have an Effect on PONV and Sore Throat?

Not Applicable

Not yet recruiting

• Conditions: Postoperative Nausea and Vomiting; Sore-throat; Dental Caries
• Interventions: Procedure: throat pack

• Registration Number: NCT06169306
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-28
• Study Start: 2024-01-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
throath pack	throat pack	Following endotracheal intubation, throath pack will inserted into the hypopharynx.

Primary Outcome Measures

Name	Time	Method
PONV	1, 2 and 6 hours	PONV scores were recorded at 1, 2 and 6 hours using the pictorial nausea scale "Baxter Retching Faces (BARF), which is scored between 0 and 10. A score of 0 on the BARF indicates the absence of PONV, while a score of 10 indicates the most severe PONV.

Secondary Outcome Measures

Name	Time	Method
sore throat	1, 2 and 6 hours	Sore throat scores were recorded at 1, 2 and 6 hours after endotracheal extubation, using the Visual Analog Scale (VAS) visual scale scored between 0 and 10. On the VAS, 0 indicates no pain, while 10 indicates the most severe pain.