NCT05343429

Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Severity and Duration of Post-Operative Sore Throat

''Comparison of Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Reduction in Severity and Duration of Post-Operative Sore Throat. A Randomized Controlled Parallel Study.''

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rehman Medical Institute - RMI · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Post-operative sore throat (POST) following General Anesthesia with endotracheal is a common symptom and drains resources. The researchers will compare preoperative gargling of Asprine and Benzydamine HCL to study comparative effects on intensity and duration of POST. Data collected as such will be analyzed to reach at a conclusion.

Detailed description

Endotracheal intubation commonly causes postoperative sore throat (POST). Its incidence is 22 - 62% in the adult population whereas in children the incidence is 24 to 44%. In adult population peak incidence is 2 to 4 hours after tracheal extubation. There is a limited medical literature available about incidence and peak time of occurrence after tracheal extubation in children. Though relieved in due course of time, POST leads to postoperative dissatisfaction. Traumatic laryngoscopy and endotracheal tube residence are the most likely offenders individually or combined. Other risk factors include preexisting upper respiratory tract infection, multiple intubation attempts, intubating un-paralyzed patient, high ETT cuff pressure, prolonged anesthesia with ETT and inexperienced operator. The problem i.e. POST preemptive amelioration, has been studied using various pharmacological interventions. The list includes, but is not limited to, Benzydamine hydrochloride, aspirin, ketamine, lidocaine and dexamethasone. In a study conducted by Agarwal A, Nath SS, Goswami D et al on adult female patients employing preoperative Aspirin and Benzydamine hydrochloride gargling found it simple, safe and effective method in reducing incidence and severity of POST. Their patients were scheduled for mastectomy. However, a study conducted by Hyung-Been Yhim, Soo-Hyuk Yoon, Young-Eun Jang et al in pediatrics was unsuccessful to show reduction in POST when they used Benzydamine hydrochloride (BH) spray on vocal cords and upper airway before tracheal intubation. They asked for more research and suggested well-designed and powered RCT's in children. The current study will differ from previously conducted research and will include adult males of different ethnicity and type of surgery. Objectives: To compare the effect of Aspirin and Benzydamine hydrochloride (BH) gargles on incidence, severity and duration of POST.

Conditions

• Sore Throat

Interventions

Type	Name	Description
DRUG	Benzydamine hydrochloride	In BN group,15 ml of 0.15 % Benzydamine hydrochloride (BN) will be dissolved in 15 ml plain water in a sterile container and given to participants before anesthesia for surgery
DRUG	Aspirin	In group AP, Aspirin (AP) 600 mg Aspirin tablets dissolved in 30 ml of plain water in a sterile container will be given to participants for gargling before anesthesia for surgery

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-10-30
• Completion: 2022-12-31
• First posted: 2022-04-25
• Last updated: 2022-05-12

Locations

1 site across 1 country: Pakistan