Benzydamine Hydrochloride and Post-operative Sore Throat

Recruiting now · Early Phase 1

Conditions studied: Sore Throat, Postoperative Care

In brief

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.

Key facts

Study ID

NCT06676748

Run by

KK Women's and Children's Hospital

People needed

106

Starts

2025-08-11

Expected to finish

2027-12-31

Last updated by the study team

2026-08-06

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• American Society of Anaesthesiologists (ASA) physical status 1-2
• Female patients having laryngeal mask airway (LMA) for airway management for surgery in KKH;
• BMI < 40 kg/m2.

You may not qualify if…

• Pregnant;
• Pre-existing sore throat, or history of upper respiratory tract infection/ abnormalities, hypertension, chronic pain or anti-inflammatory drugs and antihypertensive treatment;
• Allergies to benzydamine hydrochloride;
• Symptomatic hiatus hernia;
• Severe gastroesophageal reflux disease;
• Contraindications to the use of LMA.

Where it is running

• KK Women's and Children's Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.