drugset / Trial / NCT06676748

Benzydamine Hydrochloride and Post-operative Sore Throat

NCT06676748

Phase 0 Not yet recruiting 106 enrolled KK Women's and Children's Hospital
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2025-04
Primary completion
2025-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzydamine Unknown 3 mg/ml Topical

Indications