''Comparison of Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Reduction in Severity and Duration of Post-Operative Sore Throat. A Randomized Controlled Parallel Study.''
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of Postoperative sore throat (POST) in both groups
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
A pharmacist not part of the study will prepare two solutions, one of Benzydamine hydrochloride (BH) 0.15 % 15 ml diluted to 30 ml by adding plain water and another of Aspirin (AS) 600 mg dissolved in 30 ml plain water. The randomized patients will gargle with either BH and AS solution five minutes before conduct of General Anesthesia. The unique identification will be known only to principal investigator.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Benzydamine hydrochloride (BN)
15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container
Intervention: Benzydamine hydrochloride (Drug)
Aspirin (Ap)
600 mg Aspirin tablets dissolved in 30 ml of plain water
Intervention: Aspirin (Drug)
Outcomes
Primary Outcomes
Incidence of Postoperative sore throat (POST) in both groups
Time Frame: Six hours
Rate (incidence) of Postoperative sore throat (POST) in both groups will be calculated and compared with each other.
Secondary Outcomes
- Duration of Postoperative sore throat (POST) in both groups(Six hours post-operative period)
- Severity of Postoperative sore throat (POST) in both groups(Six hours post-operative period)
Investigators
Mohammad Shafiq
Consultant Anesthesiologist
Rehman Medical Institute - RMI