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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sore Throat

Intervention / Treatment
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* Drug: Benzydamine hydrochloride
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of American Society of Anesthesiologists Class 1 and 2 (ASA 1 and 2) scheduled for gynecological surgery under General Anesthesia with Intra tracheal Intubation and expected to finish in less than three hours will be included in the study. Patients of 18- 60 years of age will be included. Patients of Mallampati class 1 and 2 will be selected, as these have easy intubation predicted. Patients qualifying for easy intubation (prediction based on mouth opening, neck mobility etc.) will be selected. Patients in supine position only. Exclusion Criteria: Patients who are unable to gargle properly. Patients who require more than 2 attempts at intubation. Patients of Cormack-Lehane Grade 3 and 4 on direct laryngoscopy (multiple intubating attempts may be required). Patients requiring oral cavity instrumentation e.g. N/G tube placement, oral or laryngeal surgeries including tonsillectomies Patients whose head are frequently turned > 90 degrees with ETT placed in. Patients whose surgery is prolonged beyond 3 hour. Patients who require postoperative mechanical ventilation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment The study design is prospective double-blinded randomized controlled parallel trial with allocation ratio of 1:1.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benzydamine hydrochloride (BN)<br>15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container | Drug: Benzydamine hydrochloride<br>* 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<br>* Other names: BENZIRIN oral rinse 240ml by Adamjee Pharmaceuticals (Pvt.) Ltd.;|
| Active Comparator: Aspirin (Ap)<br>600 mg Aspirin tablets dissolved in 30 ml of plain water | Drug: Aspirin<br>* 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<br>* Other names: Tablets. Disprin 300 mg (soluble) by by Reckitt Benckiser (Pvt.) Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative sore throat (POST) in both groups | Rate (incidence) of Postoperative sore throat (POST) in both groups will be calculated and compared with each other. | Six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Postoperative sore throat (POST) in both groups | Based on structured proforma, participants will be followed for any complaints of POST at regular intervals and duration of POST will be calculated and compared. | Six hours post-operative period | 
| Severity of Postoperative sore throat (POST) in both groups | Severity of Postoperative sore throat (POST) in both groups will be assessed and compared. POST will be graded on a 4-point scale i.e. 0 through 3. 0 for no sore throat, 1 for mild sore throat (complaints of sore throat only upon asking), 2 for moderate sore throat (complaints of sore throat at one's own), and 3 for severe sore throat (change of voice / hoarseness; and associated with throat pain). | Six hours post-operative period |