Sore ThroatPhase 3Throat packNCT07486544
Soaked Pharyngeal Packing Agents in Septoplasty
A Phase 3 study testing dexamethasone 8mg in people with Sore Throat, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative sore throat (POST) is a frequent and distressing complication after general anesthesia with endotracheal intubation, particularly in nasal surgery for example, functional endoscopic sinus surgery, septoplasty, or septo-rhinoplasty, where pharyngeal packing is routine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- dexamethasone 8mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2026to 27 Apr 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years,
- Both male and female,
- Classified as American Society of Anesthesiologists (ASA) physical status I to III, and
- Scheduled for elective septoplasty.
Who cannot join
- Preoperative sore throat,
- Recent upper respiratory infections,
- Anticipated difficult airway,
- Existing digestive, respiratory, or cervical conditions,
- Regular smoking,
- Steroid use within 48 hours prior to surgery, and
Show all 11Show fewer
- Pregnancy.
- Patients on chronic corticosteroid therapy, antitussives, or antihypertensive medications
- With known effects on airway reactivity or bleeding risk,
- Those with uncontrolled hypertension, or
- With known allergies to any of the study medications or their components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Soaked Pharyngeal Packing Agents in Septoplasty Procedure: Impact on Postoperative Outcomes
Postoperative sore throat (POST) is a frequent and distressing complication after general anesthesia with endotracheal intubation, particularly in nasal surgery for example, functional endoscopic sinus surgery, septoplasty, or septo-rhinoplasty, where pharyngeal packing is routine. While pharyngeal packs may reduce blood ingestion, they may exacerbate POST, warranting effective pharmacologic prophylaxis. This study assesses the efficacy of dexamethasone-soaked pharyngeal packs in reducing incidence of POST in patients undergoing elective septoplasty surgeries.
Read the detailed description
Allocation will be concealed in opaque, sealed envelopes, opened only after patient recruitment. A nurse who will be blinded to the group assignment prepared the pharyngeal packs. A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made up each intervention pack. for 30 seconds, the gauze will be submerged in either 25 ml of saline solution containing dexamethasone (8 mg) or 25 ml of 0.9% saline for the control group. These dosages will be given in accordance with published data showing the safety and effectiveness of these concentrations in earlier research employing comparable quantities for anti-inflammatory and analgesic effects.
Study protocol:
Intraoperatively, standard monitoring, as advised by the ASA, will be implemented. Induction will be conducted with lidocaine (1 mg/kg), propofol (3 mg/kg), fentanyl (1 μg/kg), and rocuronium (0.8 mg/kg). Endotracheal tubes (6.5 mm for females, 7 mm for males) will be coated with 2% lidocaine jelly prior to intubation. Cuff pressures will be sustained at 20-22 cmH2O for the whole surgical procedure utilizing a manometer. The anesthetist, unaware of group allocation, will place the pharyngeal pack under direct visualization following intubation. The pharyngeal pack is situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement is executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.
Anesthesia maintenance employe sevoflurane combined with an oxygen-air combination, while intravenous fluids will be administered at a rate of 2 mL/kg/hr. Pre-extubation analgesia include 1 g of paracetamol. All intubations will be executed by experienced anesthetists, potentially reducing traumatic intubation and many attempts, which are acknowledged factors contributing to postoperative sore throat. The duration of the procedure and any oropharyngeal hemorrhaging, characterized as observable bleeding from the oropharynx during the emergence from anesthesia, will be recorded. All patients will be administered absorbable nasal packing immediately following the surgical procedure to manage hemorrhage, applied consistently across all groups. No topical anesthetics or vasoconstrictors will be administered. All patients receive standard intravenous dexamethasone (8 mg) intraoperatively in accordance with our institutional practice to avoid postoperative nausea and vomiting (PONV). Post-surgery, oropharyngeal suctioning will be conducted under direct visualization, and the pharyngeal pack is extracted once the patient regained complete consciousness, achieved hemodynamic stability, and satisfied extubation requirements. Patients are then sent to the Post-Anesthesia Care Unit (PACU). An anesthetist, unaware of group assignment, document intraoperative and postoperative data.
The primary outcome is the incidence of postoperative sore throat (POST) at 1-hour post-surgery; assessment is done at PACU every 30 min for 1 h (0, 30, 60 min). Secondary outcomes encompass the incidence and severity of POST at 3, 6, 12, and 24 hours; postoperative nausea and vomiting (PONV) scores will be documented up to 6 hours (PACU admission, 3, and 6 hours); postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) at various intervals (PACU admission, 3, 12, and 24 hours) up to 24 hours; and total postoperative pethidine consumption. POST severity is classified as a standardized 4-point scale as 0 when there is no sore throat, 1 for mild sore throat, 2 when discomfort is moderate, and 3 for severe sore throat associated with hoarseness. PONV is assessed and documented by the PACU nurses using a verbal descriptive score aligned with a visual analogue nausea scale, facilitating an objective assessment of severity. A score of 0 indicated the absence of nausea and vomiting post-surgery, 1 denoted mild postoperative nausea without vomiting or the necessity for antiemetics, 2 signified moderate nausea post-surgery necessitating antiemetic intervention, and 3 represented postoperative nausea accompanied by vomiting, and 8 mg IV ondansetron will be given at grade 2. Pain intensity is assessed using a 10 cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 the worst imaginable pain. Pain severity is categorized as mild (0-3), moderate (4-6), or severe (7-10). Pethidine 0.5 mg/kg is administered for scores ≥4. All assessments will be conducted by observers blinded to the groups.
- Conditions
- Sore Throat
- Being tested
- Saline (NaCl 0,9 %) (placebo), dexamethasone 8mg
- Keywords
- Pharyngitis, Pharynx, Nasal Surgical Procedures, Dexamethasone
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (NaCl 0,9 %) (placebo)Other
The anesthetist, unaware of group allocation, will place the saline soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.
dexamethasone 8mgDrug
The anesthetist, unaware of group allocation, will place the dexamethasone soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made, then for 30 seconds, the gauze is submerged in 25 ml of normal saline solution Receives: Other: Saline (NaCl 0,9 %) (placebo) |
| Dexamethasone | Active comparator | A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made, then for 30 seconds, the gauze is submerged in 8 mg dexamethasone and 25 ml of normal saline solution Receives: Drug: dexamethasone 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat (POST) score: 4-point scale as 0 for no sore throat (better outcome), and 3 for severe sore throat associated with hoarseness (worse outcome).
The incidence of postoperative sore throat (POST) at 1-hour post-surgery and assessment will be done at Post Anesthesia Care Unit (PACU) every 30 minutes for 1 hour (at Post Anesthesia Care Unit (PACU) admission, 30, and 60 minutes).
Measured: 1 hour
Secondary outcomes (3)
Postoperative Sore Throat (POST) score: 4-point scale as 0 for no sore throat (better outcome) and 3 for severe sore throat associated with hoarseness (worse outcome).
The incidence and severity of Postoperative Sore Throat (POST) at 3, 6, 12, and 24 hours post surgery
Measured: 24 hours
Postoperative nausea and vomiting (PONV) score: A 4-point scale with 0 for absence of nausea and vomiting (better outcome), and 3 for postoperative nausea accompanied by vomiting (worse outcome).
Postoperative nausea and vomiting scores documented up to 6 hours (PACU admission, 3, and 6 hours)
Measured: 6 hours
Visual Analogue Scale (VAS) pain score: a 10 cm Visual Analog Scale, where 0 indicated no pain (better outcome), and 10 the worst imaginable pain (worse outcome).
Postoperative pain intensity evaluated using the Visual Analogue Scale (VAS) at various intervals (PACU admission, 3, 12, and 24 hours) up to 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Mar 2026
- Primary completion25 Apr 2026
- Study completion27 Apr 2026
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 Sore ThroatStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486544
- Sponsor's protocol ID
- 04-2026-300826
- Acronym
- Throat pack
- Status last verified
- May 2026
- First submitted
- 16 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.
PubMed 38074131
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Soaked Pharyngeal Packing Agents in Septoplasty Procedure: Impact on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT07486544
- Acronym / sponsor ID
- Throat pack / 04-2026-300826
- Conditions
- Sore Throat
- Keywords
- Pharyngitis, Pharynx, Nasal Surgical Procedures, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 20 Mar 2026 (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.
Postoperative sore throat (POST) is a frequent and distressing complication after general anesthesia with endotracheal intubation, particularly in nasal surgery for example, functional endoscopic sinus surgery, septoplasty, or septo-rhinoplasty, where pharyngeal packing is routine. While pharyngeal packs may reduce blood ingestion, they may exacerbate POST, warranting effective pharmacologic prophylaxis. This study assesses the efficacy of dexamethasone-soaked pharyngeal packs in reducing incidence of POST in patients undergoing elective septoplasty surgeries.
Detailed description
Allocation will be concealed in opaque, sealed envelopes, opened only after patient recruitment. A nurse who will be blinded to the group assignment prepared the pharyngeal packs. A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made up each intervention pack. for 30 seconds, the gauze will be submerged in either 25 ml of saline solution containing dexamethasone (8 mg) or 25 ml of 0.9% saline for the control group. These dosages will be given in accordance with published data showing the safety and effectiveness of these concentrations in earlier research employing comparable quantities for anti-inflammatory and analgesic effects.
Study protocol:
Intraoperatively, standard monitoring, as advised by the ASA, will be implemented. Induction will be conducted with lidocaine (1 mg/kg), propofol (3 mg/kg), fentanyl (1 μg/kg), and rocuronium (0.8 mg/kg). Endotracheal tubes (6.5 mm for females, 7 mm for males) will be coated with 2% lidocaine jelly prior to intubation. Cuff pressures will be sustained at 20-22 cmH2O for the whole surgical procedure utilizing a manometer. The anesthetist, unaware of group allocation, will place the pharyngeal pack under direct visualization following intubation. The pharyngeal pack is situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement is executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.
Anesthesia maintenance employe sevoflurane combined with an oxygen-air combination, while intravenous fluids will be administered at a rate of 2 mL/kg/hr. Pre-extubation analgesia include 1 g of paracetamol. All intubations will be executed by experienced anesthetists, potentially reducing traumatic intubation and many attempts, which are acknowledged factors contributing to postoperative sore throat. The duration of the procedure and any oropharyngeal hemorrhaging, characterized as observable bleeding from the oropharynx during the emergence from anesthesia, will be recorded. All patients will be administered absorbable nasal packing immediately following the surgical procedure to manage hemorrhage, applied consistently across all groups. No topical anesthetics or vasoconstrictors will be administered. All patients receive standard intravenous dexamethasone (8 mg) intraoperatively in accordance with our institutional practice to avoid postoperative nausea and vomiting (PONV). Post-surgery, oropharyngeal suctioning will be conducted under direct visualization, and the pharyngeal pack is extracted once the patient regained complete consciousness, achieved hemodynamic stability, and satisfied extubation requirements. Patients are then sent to the Post-Anesthesia Care Unit (PACU). An anesthetist, unaware of group assignment, document intraoperative and postoperative data.
The primary outcome is the incidence of postoperative sore throat (POST) at 1-hour post-surgery; assessment is done at PACU every 30 min for 1 h (0, 30, 60 min). Secondary outcomes encompass the incidence and severity of POST at 3, 6, 12, and 24 hours; postoperative nausea and vomiting (PONV) scores will be documented up to 6 hours (PACU admission, 3, and 6 hours); postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) at various intervals (PACU admission, 3, 12, and 24 hours) up to 24 hours; and total postoperative pethidine consumption. POST severity is classified as a standardized 4-point scale as 0 when there is no sore throat, 1 for mild sore throat, 2 when discomfort is moderate, and 3 for severe sore throat associated with hoarseness. PONV is assessed and documented by the PACU nurses using a verbal descriptive score aligned with a visual analogue nausea scale, facilitating an objective assessment of severity. A score of 0 indicated the absence of nausea and vomiting post-surgery, 1 denoted mild postoperative nausea without vomiting or the necessity for antiemetics, 2 signified moderate nausea post-surgery necessitating antiemetic intervention, and 3 represented postoperative nausea accompanied by vomiting, and 8 mg IV ondansetron will be given at grade 2. Pain intensity is assessed using a 10 cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 the worst imaginable pain. Pain severity is categorized as mild (0-3), moderate (4-6), or severe (7-10). Pethidine 0.5 mg/kg is administered for scores ≥4. All assessments will be conducted by observers blinded to the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo)A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made, then for 30 seconds, the gauze is submerged in 25 ml of normal saline solution |
| Dexamethasone | Active comparator | Drug: dexamethasone 8mgA sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made, then for 30 seconds, the gauze is submerged in 8 mg dexamethasone and 25 ml of normal saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years,
- Both male and female,
- Classified as American Society of Anesthesiologists (ASA) physical status I to III, and
- Scheduled for elective septoplasty.
Key exclusion criteria (11 listed)
- Preoperative sore throat,
- Recent upper respiratory infections,
- Anticipated difficult airway,
- Existing digestive, respiratory, or cervical conditions,
- Regular smoking,
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 |
|---|---|---|
| Saline (NaCl 0,9 %) (placebo)The anesthetist, unaware of group allocation, will place the saline soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients. | Other | Placebo |
| dexamethasone 8mgThe anesthetist, unaware of group allocation, will place the dexamethasone soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients. | Drug | Dexamethasone |
Primary outcome
Postoperative sore throat (POST) score: 4-point scale as 0 for no sore throat (better outcome), and 3 for severe sore throat associated with hoarseness (worse outcome).
Time frame: 1 hour
The incidence of postoperative sore throat (POST) at 1-hour post-surgery and assessment will be done at Post Anesthesia Care Unit (PACU) every 30 minutes for 1 hour (at Post Anesthesia Care Unit (PACU) admission, 30, and 60 minutes).
3 secondary outcomes
Postoperative Sore Throat (POST) score: 4-point scale as 0 for no sore throat (better outcome) and 3 for severe sore throat associated with hoarseness (worse outcome).
Time frame: 24 hours
Postoperative nausea and vomiting (PONV) score: A 4-point scale with 0 for absence of nausea and vomiting (better outcome), and 3 for postoperative nausea accompanied by vomiting (worse outcome).
Time frame: 6 hours
Visual Analogue Scale (VAS) pain score: a 10 cm Visual Analog Scale, where 0 indicated no pain (better outcome), and 10 the worst imaginable pain (worse outcome).
Time frame: 24 hours
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 7 May 2026.
- Results publication: PubMed 38074131Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 3 study testing dexamethasone 8mg in people with Sore Throat, run by Assiut University at 1 site in Egypt.
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 11 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 7 May 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 sore throat (POST) score: 4-point scale as 0 for no sore throat (better outcome), and 3 for severe sore throat associated with hoarseness (worse outcome). (time frame: 1 hour). 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 NCT07486544, 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 7 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.