RecruitingEarly Phase 1NCT06676748

Benzydamine Hydrochloride and Post-operative Sore Throat

The Effect of Benzydamine Hydrochloride Spray on Post-operative Sore Throat: a Randomized Controlled Study


Sponsor

KK Women's and Children's Hospital

Enrollment

106 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Postoperative sore throat (POST) after laryngeal mask airway (LMA) insertion is prevalent and unappealing. A significant cause of POST is mechanical injury to the airway mucosa during airway instrumentation, leading to mucosal injury and inflammation. The Difflam Forte Anti-Inflammatory Throat Spray (Difflam) contains benzydamine hydrochloride, a non-steroidal anti-inflammatory agent with topical analgesic properties. This study will randomize 106 women undergoing gynaecological surgery under general anaesthesia with LMA use at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of study (Difflam spray) and control (usual practice; no intervention) groups. Demographic and intraoperative airway data collection will be conducted in perioperative period. Those allocated to study group will receive Difflam spray when awake in the post-anaesthesia care unit (PACU). The primary aim to determine if patients undergoing general anaesthesia with LMA use with the Difflam spray in PACU will have a lower incidence of POST in the immediate and 4 hours postoperative recovery period, as compared with those in the control group. Other outcome measures include the severity of pain of sore throat as measured by the visual analog scale, and incidence of side effects associated with the Difflam spray. This proposal will determine whether the use of Difflam spray is suitable to be implemented in local clinical setting and improve perioperative care.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Benzydamine Hydrochloride for people with postoperative care and sore-throat. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 21 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBenzydamine Hydrochloride

The Difflam Forte Anti-Inflammatory Throat Spray (iNova Pharmaceuticals Pte Ltd, Singapore) is an over-the-counter medication indicated for temporary relief of painful mouth and throat conditions. It contains benzydamine hydrochloride (BH) 3 mg/mL, a non-steroidal anti-inflammatory agent (NSAID), and is recommended for adults to spray 2 to 4 times to the affected throat every 1.5 to 3 hours as needed.


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06676748


Related Trials