Soaked Pharyngeal Packing Agents in Septoplasty (Throat pack)

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.

Study Overview

• Status: Completed
• Conditions: Sore Throat
• Intervention / Treatment: Other: Saline (NaCl 0,9 %) (placebo); Drug: dexamethasone 8mg

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71511
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Other: 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.
Active Comparator: Dexamethasone; 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	Drug: dexamethasone 8mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Actual): April 25, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dexamethasone; Pharyngitis; Pharynx; Nasal Surgical Procedures
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: 04-2026-300826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No