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NCT Number: NCT06676748

Benzydamine Hydrochloride and Post-operative Sore Throat

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.

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Key information

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

Postoperative sore throat (POST) after laryngeal mask airway (LMA) insertion is common, with reported incidences being as high as 40 - 60%. This is in spite of ongoing efforts to address this pertinent issue, including utilization of updated iterations of LMA devices, reduction of LMA cuff pressure, etc.. POST is an independent predictor of patient dissatisfaction following general anaesthesia and should be investigated further.

The cause of POST is multifactorial, with various mechanisms at play. A significant cause of POST is mechanical injury to the airway mucosa during airway instrumentation, leading to mucosal injury and inflammation. While the application of topical lidocaine on airway mucosa after surgery for analgesic relief may seem to be a possible solution, this may however, increase the risk of aspiration due to diminished cough reflex and swallowing ability. On the other hand, mouth gargles with analgesics may not provide immediate relief for POST as they require much cooperation from the patient that proves to be challenging in the immediate postoperative period.

The Difflam Forte Anti-Inflammatory Throat Spray 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. The effectiveness of benzydramine on alleviating sore throat has been well established in modern medicine. However, a spray formulation of this medication has not been utilized for this purpose yet. With the spray formulation, patient cooperation will not be required for effective delivery of BH medication - a critical factor in view of patient drowsiness post operation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Benzydamine Hydrochloride

Drug

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.

Other names: benzydamine hydrochloride 3 mg/mL, Difflam Forte Anti-Inflammatory Throat Spray

Primary outcomes

  1. Postoperative sore throat

    Time frame: 1 day; from the immediate and 4 hours postoperative recovery period

    Presence of postoperative sore throat (POST) during the immediate and 4 hours postoperative recovery period. At these two time points patients will be asked whether they have sore throat; and answering 'yes' will be considered as 'POST present'.

Secondary outcomes

  1. Postoperative pain score

    Time frame: 1 day; from the immediate and 4 hours postoperative recovery period

    Pain score during the immediate and 4 hours postoperative recovery period after intervention (Visual analog scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.

  2. Side effects

    Time frame: 1 day; from the immediate and 4 hours postoperative recovery period

    Presence of side effects during the immediate and 4 hours postoperative recovery period. At these two time points patients will be asked whether they have burning and/or stinging, dry mouth, cough, local numbness; and answering 'yes' will be considered as 'burning and/or stinging, dry mouth, cough, local numbness present'.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Acronym: DIFFLAM

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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