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

Primary Purpose

Sore Throat

Status
Recruiting
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Benzydamine hydrochloride
Aspirin
Sponsored by
Rehman Medical Institute - RMI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rehman Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Benzydamine hydrochloride (BN)

Aspirin (Ap)

Arm Description

15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container

600 mg Aspirin tablets dissolved in 30 ml of plain water

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
April 18, 2022
Last Updated
May 6, 2022
Sponsor
Rehman Medical Institute - RMI
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1. Study Identification

Unique Protocol Identification Number
NCT05343429
Brief Title
Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Severity and Duration of Post-Operative Sore Throat
Acronym
Postbenas
Official Title
''Comparison of Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Reduction in Severity and Duration of Post-Operative Sore Throat. A Randomized Controlled Parallel Study.''
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rehman Medical Institute - RMI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment The study design is prospective double-blinded randomized controlled parallel trial with allocation ratio of 1:1.
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Benzydamine hydrochloride (BN)
Arm Type
Active Comparator
Arm Description
15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container
Arm Title
Aspirin (Ap)
Arm Type
Active Comparator
Arm Description
600 mg Aspirin tablets dissolved in 30 ml of plain water
Intervention Type
Drug
Intervention Name(s)
Benzydamine hydrochloride
Other Intervention Name(s)
BENZIRIN oral rinse 240ml by Adamjee Pharmaceuticals (Pvt.) Ltd.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Tablets. Disprin 300 mg (soluble) by by Reckitt Benckiser (Pvt.) Ltd.
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Postoperative sore throat (POST) in both groups
Description
Rate (incidence) of Postoperative sore throat (POST) in both groups will be calculated and compared with each other.
Time Frame
Six hours
Secondary Outcome Measure Information:
Title
Duration of Postoperative sore throat (POST) in both groups
Description
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.
Time Frame
Six hours post-operative period
Title
Severity of Postoperative sore throat (POST) in both groups
Description
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).
Time Frame
Six hours post-operative period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Shafiq, FCPS
Phone
+92-91-5838000
Ext
2394
Email
mohammad.shafiq@rmi.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Rahman U Jan, MCPS
Phone
+92-3339749567
Email
janrahman21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Shafiq, FCPS
Organizational Affiliation
Rehman Medical institute, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehman Medical Institute
City
Peshawar
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Shafiq, FCPS
Phone
+92-91-5838000
Ext
2394
Email
mohammad.shafiq@rmi.edu.pk
First Name & Middle Initial & Last Name & Degree
Rahman U Jan, MCPS
Phone
+92-3339749567
Email
janrahman21@gmail.com
First Name & Middle Initial & Last Name & Degree
Rahman U Jan, MCPS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
11871952
Citation
Chandler M. Tracheal intubation and sore throat: a mechanical explanation. Anaesthesia. 2002 Feb;57(2):155-61. doi: 10.1046/j.1365-2044.2002.02329.x.
Results Reference
background
PubMed Identifier
23991600
Citation
Piriyapatsom A, Dej-Arkom S, Chinachoti T, Rakkarnngan J, Srishewachart P. Postoperative sore throat: incidence, risk factors, and outcome. J Med Assoc Thai. 2013 Aug;96(8):936-42.
Results Reference
result
PubMed Identifier
27158989
Citation
El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
Results Reference
result
PubMed Identifier
22066487
Citation
Calder A, Hegarty M, Erb TO, von Ungern-Sternberg BS. Predictors of postoperative sore throat in intubated children. Paediatr Anaesth. 2012 Mar;22(3):239-43. doi: 10.1111/j.1460-9592.2011.03727.x. Epub 2011 Nov 8.
Results Reference
result
PubMed Identifier
22174478
Citation
Patki A. Laryngeal mask airway vs the endotracheal tube in paediatric airway management: A meta-analysis of prospective randomised controlled trials. Indian J Anaesth. 2011 Sep;55(5):537-41. doi: 10.4103/0019-5049.89900.
Results Reference
result
Citation
Mostafa RH, Saleh AN, Hussein MM. A comparative study of three nebulized medications for the prevention of postoperative sore throat in the pediatric population. Open Anesthesia J. 2018;12(1):85-93.
Results Reference
result
PubMed Identifier
24263969
Citation
Chen CY, Kuo CJ, Lee YW, Lam F, Tam KW. Benzydamine hydrochloride on postoperative sore throat: a meta-analysis of randomized controlled trials. Can J Anaesth. 2014 Mar;61(3):220-8. doi: 10.1007/s12630-013-0080-y. Epub 2013 Nov 22.
Results Reference
result
PubMed Identifier
17000820
Citation
Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Anesth Analg. 2006 Oct;103(4):1001-3. doi: 10.1213/01.ane.0000231637.28427.00.
Results Reference
result
PubMed Identifier
26470672
Citation
Mayhood J, Cress K. Effectiveness of ketamine gargle in reducing postoperative sore throat in patients undergoing airway instrumentation: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep;13(9):244-78. doi: 10.11124/jbisrir-2015-2045.
Results Reference
result
PubMed Identifier
26171894
Citation
Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
Results Reference
result
PubMed Identifier
30617677
Citation
Kuriyama A, Maeda H. Preoperative intravenous dexamethasone prevents tracheal intubation-related sore throat in adult surgical patients: a systematic review and meta-analysis. Can J Anaesth. 2019 May;66(5):562-575. doi: 10.1007/s12630-018-01288-2. Epub 2019 Jan 7.
Results Reference
result
PubMed Identifier
32247315
Citation
Yhim HB, Yoon SH, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 4;20(1):77. doi: 10.1186/s12871-020-00995-y.
Results Reference
result

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

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