An interventional study of Flurbiprofen 8.75 MG and Saline spray in Post Operative Sore Throat and Hoarseness, sponsored by Kittitorn Supphapipat, MD. Active, not recruiting at 1 site in Thailand. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Kittitorn Supphapipat, MD · Not applicable, Interventional, and Prevention
The goal of this study is to evaluate whether topical flurbiprofen reduces the incidence and severity of postoperative sore throat (POST) and hoarseness in patients undergoing double-lumen tube (DLT) intubation for elective thoracic surgery.
The main question is: Does topical flurbiprofen reduce POST and hoarseness compared with placebo in patients undergoing DLT intubation? Researchers will compare topical flurbiprofen spray with placebo spray.
Participants will:
Postoperative sore throat (POST) is a common complication after general anesthesia involving airway manipulation, with reported incidence rates of up to 62%. It includes a spectrum of symptoms such as throat pain, pharyngitis, laryngitis, tracheitis, cough, hoarseness, and dysphagia, typically occurring in the early postoperative period. Although generally self-limiting, severe cases may cause dyspnea and dysphagia, reduce patient satisfaction, and in some cases prolong hospital stay.
POST results from laryngeal and tracheal mucosal injury during tracheal intubation. The pathophysiology is multifactorial, involving direct airway trauma, mucosal irritation and inflammation, ischemia from cuff compression, regurgitation of gastric contents, and gastric tube placement. Risk factors include female sex, younger age, smoking, lung disease, prolonged surgery, patient repositioning, difficult intubation, larger tube diameter, stylet use, high cuff pressure, and frequent suctioning.
The use of double-lumen tubes (DLTs), required for thoracic surgery with one-lung ventilation, has been associated with an even higher incidence of POST due to larger tube size, stylet-assisted insertion, and increased glottic trauma.
Several strategies have been investigated to prevent POST, including cuff pressure control, local anaesthetics, corticosteroids, and nonsteroidal anti-inflammatory drugs (NSAIDs). Dexamethasone and lidocaine have shown some benefit, but results are inconsistent, and POST remains prevalent in clinical practice.
Flurbiprofen, a nonsteroidal anti-inflammatory drug, is available as an oromucosal spray (8.75 mg/dose) and is widely used for sore throat relief in general practice. It reduces airway inflammation and provides analgesia when applied locally. Previous studies suggest that flurbiprofen spray applied to the cuff of laryngeal mask airways or single-lumen tubes reduces POST severity. However, limited evidence is available in the setting of DLT intubation, which carries a higher risk of POST.
This randomized, double-blind, placebo-controlled trial will investigate whether topical flurbiprofen spray applied to the cuff of a DLT before intubation reduces the incidence and severity of POST and hoarseness in patients undergoing elective thoracic surgery. Participants will be randomized to receive either topical flurbiprofen spray or placebo, with outcomes assessed at multiple time points up to 48 hours postoperatively. The study will be conducted at a single academic center, with standardized anesthesia management and blinding of patients, clinicians, and outcome assessors.
52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.
This study's planned enrollment of 58 is below the median of 108 across 44 interventional studies indexed under Hoarseness.
Browse Hoarseness studies →This is the only study on the registry with Kittitorn Supphapipat, MD as lead sponsor.
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Exclusion Criteria:
Withdrawal criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive topical flurbiprofen spray (one spray on the bronchial cuff and two spray on the tracheal cuff, with a total dose of 8.75 mg of flurbiprofen) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation
Drug: Flurbiprofen 8.75 MG
Participants will receive placebo spray (0.9% normal saline) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation.
Drug: Saline spray
Topical administration of flurbiprofen 8.75 mg spray applied directly to the tracheal and bronchial cuffs of the double-lumen endobronchial tube before intubation. A total of three sprays will be applied: one spray to the bronchial cuff and two sprays to the tracheal cuff, immediately before intubation.
Also known as: Flurbiprofen spray
Topical administration of placebo spray (0.9% normal saline) applied in the same manner as the active intervention, with one spray to the bronchial cuff and two sprays to the tracheal cuff of the double-lumen tube before intubation.
Incidence of POST
Presence or absence of postoperative sore throat (POST)
Time frame: Within 48 hours postoperatively
Severity of POST
Severity of sore throat measured using a numerical rating scale (0-10) and throat pain scale (TPS: 0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Incidence of hoarseness
Presence or absence of hoarseness
Time frame: Within 48 hours postoperatively
Severity of hoarseness
Severity of hoarseness measured using a 4-point scale (HOAR: 0 = none, 1 = minimal, 2 = moderate, 3 = severe)
Time frame: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Patient satisfaction
Overall patient satisfaction intubation, measured using a 10-point satisfaction scale (0 = not satisfied, 10 = very satisfied)
Time frame: 48 hours postoperatively
Plan to share: Undecided — Individual participant data will not be shared because this is a single-centre investigator-initiated study with a limited sample size, and the data contain potentially sensitive patient information. De-identified summary data may be made available upon reasonable request to the principal investigator
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 15 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Flurbiprofen