Benzydamine Hydrochloride and Post-operative Sore Throat

NCT06676748 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2021/2264
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sore Throat; Postoperative Care

Keywords

Sore throat; Posoperative care; benzydamine hydrochloride; laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• Postoperative sore throat

  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'.

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

Secondary Outcomes (2)

• Postoperative pain score

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

• Side effects

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

Study Arms (2)

Study group

EXPERIMENTAL

Study group will receive Difflam spray by delivering 4 sprays to the posterior pharynx. Patients will be asked to swallow after each spray. Questionnaires will then be administered to the patients 10 minutes after administration of the intervention, and then 4 hours after for their pain scores and side effects, if any.

Drug: Benzydamine Hydrochloride

Control group

NO INTERVENTION

Patients will be asked to fill in questionnaires for their pain scores and side effects, if any.

Interventions

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.

Also known as: benzydamine hydrochloride 3 mg/mL, Difflam Forte Anti-Inflammatory Throat Spray

Study group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: The participating site is a specialised hospital only for women and children.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Benzydamine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study uses a randomized (1:1 allocation ratio) and single-blinded trial design. Block randomization will be used to randomly assign patients to no intervention i.e., usual practice (Control) and BH (Difflam) spray (study) groups in a 1:1 allocation ratio based on a computer-generated code that will be prepared at a remote site and sealed in opaque, sequentially numbered envelopes.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)