Sore ThroatPhase 4NCT03574246
Effects of Two Packing Type in Maxillofacial Surgery
A Phase 4 study testing chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and %0.9 NaCl Solution in people with Sore Throat and Nausea and Vomiting, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sore Throat, Nausea and Vomiting, Postoperative
- What is being tested?
- chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and %0.9 NaCl Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 22 Dec 2018
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
- ASA 1-2 groups of patients
- Patients who have completed growth and development
- Patients who are willing to comply with the requirements of the study
- Patients with complete medical records
- Operations expected to last at least 2 hours
Who cannot join
- Patients with severe systemic disease other than ASA 1-2
- Difficult entubation story
- Patients with BMI> 35 kg / m2
- Contraindications for the use of NSAIDs
- Patients with diclofenac sodium and metoclopramide allergy
- Patients whose medical records are inadequate
- Patients with major tranquilizer or opiate addiction
- Patients with mental and physical anxiety that would interfere with cooperative operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06560
About this study
Official title: The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery
Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.
- Conditions
- Sore Throat, Nausea and Vomiting, Postoperative
- Being tested
- chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15, %0.9 NaCl Solution
- Medical subject headings
- Pharyngitis, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15Drug
chlorhexidine gluconate + benzydamine hydrochloride oral rinse
%0.9 NaCl SolutionOther
isotonic sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| CHXBNZ | Experimental | Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx Receives: Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 |
| SF | Active comparator | Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx Receives: Other: %0.9 NaCl Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Measured: Postoperatively 2nd hour
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Measured: Postoperatively 4th hour
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Measured: Postoperatively 6th hour
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Measured: Postoperatively 12th hour
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Measured: Postoperatively 24th hour
Secondary outcomes (6)
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 5th minute
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 10th minute
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 15th minute
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 30th minute
Nausea and Vomiting
Measurements with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 60th minute
Nausea and Vomiting
Measurements with 4 point scale 0 no nausea
- mild nausea
- severe nausea
- vomiting
- severe and continuously vomiting
Measured: Postoperatively 120th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start10 Jan 2018
- Primary completion15 Dec 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by Ankara 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagil Vural, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574246
- Sponsor's protocol ID
- 36290600/127
- Status last verified
- Feb 2019
- First submitted
- 24 May 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT03574246
- Acronym / sponsor ID
- 36290600/127
- Conditions
- Sore Throat, Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 29 Jun 2018 (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.
Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHXBNZ | Experimental | Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx |
| SF | Active comparator | Other: %0.9 NaCl SolutionPharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
- ASA 1-2 groups of patients
- Patients who have completed growth and development
- Patients who are willing to comply with the requirements of the study
- Patients with complete medical records
Key exclusion criteria (8 listed)
- Patients with severe systemic disease other than ASA 1-2
- Difficult entubation story
- Patients with BMI> 35 kg / m2
- Contraindications for the use of NSAIDs
- Patients with diclofenac sodium and metoclopramide allergy
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 |
|---|---|---|
| chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15chlorhexidine gluconate + benzydamine hydrochloride oral rinse | Drug | CHXBNZ |
| %0.9 NaCl Solutionisotonic sodium chloride | Other | SF |
Primary outcome
Postoperative Pain
Time frame: Postoperatively 2nd hour
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Time frame: Postoperatively 4th hour
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Time frame: Postoperatively 6th hour
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Time frame: Postoperatively 12th hour
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Time frame: Postoperatively 24th hour
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
6 secondary outcomes
Nausea and Vomiting
Time frame: Postoperatively 5th minute
Nausea and Vomiting
Time frame: Postoperatively 10th minute
Nausea and Vomiting
Time frame: Postoperatively 15th minute
Nausea and Vomiting
Time frame: Postoperatively 30th minute
Nausea and Vomiting
Time frame: Postoperatively 60th minute
Nausea and Vomiting
Time frame: Postoperatively 120th minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and %0.9 NaCl Solution in people with Sore Throat and Nausea and Vomiting, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Postoperatively 2nd hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2019.