Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Severity and Duration of Post-Operative Sore Throat
NCT ID: NCT05343429
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-04-01
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Benzydamine hydrochloride (BN)
15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container
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
Aspirin (Ap)
600 mg Aspirin tablets dissolved in 30 ml of plain water
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
FEMALE
Yes
Sponsors
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Rehman Medical Institute - RMI
OTHER
Responsible Party
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Mohammad Shafiq
Consultant Anesthesiologist
Principal Investigators
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Mohammad Shafiq, FCPS
Role: PRINCIPAL_INVESTIGATOR
Rehman Medical institute, Pakistan
Locations
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Rehman Medical Institute
Peshawar, Khyber Pakhtunkhwa, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RMI/RMI-REC/Approval/122
Identifier Type: -
Identifier Source: org_study_id
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