Postoperative Nausea and VomitingNCT06169306
Do Throat Pack Used in Dental Treatments Under General Anesthesia of Patients Have an Effect on PONV and Sore Throat?
A study testing throat pack in people with Postoperative Nausea and Vomiting and Sore-throat, run by Cukurova University.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Sore-throat, Dental Caries
- What is being tested?
- throat pack
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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?
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.
- Being tested
- throat pack
- Keywords
- PONV, sore throath, throath pack, special health care needs
- Medical subject headings
- Postoperative Nausea and Vomiting, Pharyngitis, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
throat packProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: throat pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1, 2 and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Tetiker, Cukurova University
- Investigators
- Sibel Tetiker, Principal investigator, Cukurova University Faculty of Dentistry, Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169306
- Sponsor's protocol ID
- CUDHF-PABD
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT06169306
- Acronym / sponsor ID
- CUDHF-PABD
- Keywords
- PONV, sore throath, throath pack, special health care needs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Following endotracheal intubation, no throath pack will inserted into the hypopharynx. |
| throath pack | Experimental | Procedure: throat packFollowing endotracheal intubation, throath pack will inserted into the hypopharynx. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| throat packFollowing 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. | Procedure or surgery | throath pack |
Primary outcome
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 secondary outcome
sore throat
Time frame: 1, 2 and 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 39860573Tetiker 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.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Tetiker principal investigator
Cukurova University Faculty of Dentistry, Pediatric Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing throat pack in people with Postoperative Nausea and Vomiting and Sore-throat, run by Cukurova University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel Tetiker, MD (+905337217723, sibeltetster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: 1, 2 and 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.