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

December 21, 2023 updated by: Sibel Tetiker, Cukurova University

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Following endotracheal intubation, no throath pack will inserted into the hypopharynx.
Experimental: throath pack
Following endotracheal intubation, throath pack will inserted into the hypopharynx.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV
Time Frame: 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.
1, 2 and 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sore throat
Time Frame: 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.
1, 2 and 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Sibel Tetiker, Cukurova University Faculty of Dentistry, Pediatric Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUDHF-PABD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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