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

NCT06169306 | Unknown

• 1 other identifier: CUDHF-PABD
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting; Sore-throat; Dental Caries

Keywords

PONV; sore throath; throath pack; special health care needs

Outcome Measures

Primary Outcomes (1)

• PONV

  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.

  1, 2 and 6 hours

Secondary Outcomes (1)

• sore throat

  1, 2 and 6 hours

Study Arms (2)

control

NO INTERVENTION

Following endotracheal intubation, no throath pack will inserted into the hypopharynx.

throath pack

EXPERIMENTAL

Following endotracheal intubation, throath pack will inserted into the hypopharynx.

Procedure: throat pack

Interventions

throat pack PROCEDURE

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.

throath pack

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Related Publications (1)

• 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.

  PMID: 39860573 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pharyngitis; Dental Caries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Tooth Demineralization; Tooth Diseases

Study Officials

• Sibel Tetiker

  Cukurova University Faculty of Dentistry, Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel Tetiker, MD

CONTACT

+905337217723; sibeltetster@gmail.com

Hacer N Uğuz

CONTACT

+905052856619; nidaauguz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 30, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12