ClinicalTrials.gg
Status unknownNCT06169306Updated Dec 28, 2023

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

An interventional study of throat pack in Postoperative Nausea and Vomiting, Sore-throat and Dental Caries, sponsored by Cukurova University. Status unknown. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-28.

Sponsored by Cukurova University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
5 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
  • Sore-throat
  • Dental Caries

Keywords

  • PONV
  • sore throath
  • throath pack
  • special health care needs
03

In context

Postoperative Nausea and Vomiting

629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.

This study's planned enrollment of 74 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Cukurova University is the lead sponsor of 257 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurethroat 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.

06

What researchers measure

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.

    Time frame: 1, 2 and 6 hours

Secondary outcomes

  1. sore throat

    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.

    Time frame: 1, 2 and 6 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 39860573 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06169306
Responsible party
Sibel Tetiker (Lecturer, Cukurova University) — Principal investigator
First posted
Dec 13, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Dec 28, 2023

Study contacts

Sibel Tetiker, MD
Contact
sibeltetster@gmail.com
+905337217723
Hacer N Uğuz
Contact
nidaauguz@hotmail.com
+905052856619
Sibel Tetiker
principal investigator · Cukurova University Faculty of Dentistry, Pediatric Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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