Benzydamine Hydrochloride and Post-operative Sore Throat

Launched by KK WOMEN'S AND CHILDREN'S HOSPITAL · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of Difflam Forte Anti-Inflammatory Throat Spray, which contains a medication called benzydamine hydrochloride, to see if it can help reduce sore throats after surgery. Many women experience sore throats after undergoing gynecological surgery with a laryngeal mask airway (LMA), a device used to help with breathing during anesthesia. The trial will include 106 female participants who are healthy enough for surgery and have a body mass index (BMI) under 40. Those who are pregnant or have certain health conditions, like severe allergies or pre-existing sore throats, will not be eligible to participate.

If you join the trial, you will be randomly assigned to either receive the Difflam spray after waking up from surgery or to follow the usual care without any special treatment. The goal is to find out if using this spray can lower the chances of having a sore throat right after surgery and in the hours that follow. Researchers will also look at how much pain participants feel in their throats and if there are any side effects from the spray. This study could help improve care for patients after surgery in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. American Society of Anaesthesiologists (ASA) physical status 1-2
• • 2. Female patients having laryngeal mask airway (LMA) for airway management for surgery in KKH;
• • 3. BMI \< 40 kg/m2.
• Exclusion Criteria:
• • 1. Pregnant;
• • 2. Pre-existing sore throat, or history of upper respiratory tract infection/ abnormalities, hypertension, chronic pain or anti-inflammatory drugs and antihypertensive treatment;
• • 3. Allergies to benzydamine hydrochloride;
• • 4. Symptomatic hiatus hernia;
• • 5. Severe gastroesophageal reflux disease;
• • 6. Contraindications to the use of LMA.