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

May 6, 2022 updated by: Mohammad Shafiq, Rehman Medical Institute - RMI

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Recruiting
        • Rehman Medical Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rahman U Jan, MCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Postoperative sore throat (POST) in both groups
Time Frame: Six hours post-operative period
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
Time Frame: Six hours post-operative period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehman Medical Institute - RMI

Investigators

  • Principal Investigator: Mohammad Shafiq, FCPS, Rehman Medical institute, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMI/RMI-REC/Approval/122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.

IPD Sharing Time Frame

April, 2022 to April, 2025

IPD Sharing Access Criteria

IPD will be shared on inter institutional request basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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