Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzydamine hydrochloride (BN) | Active Comparator | 15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container |
|
| Aspirin (Ap) | Active Comparator | 600 mg Aspirin tablets dissolved in 30 ml of plain water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzydamine hydrochloride | Drug | 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Shafiq, FCPS | Contact | +92-91-5838000 | 2394 | mohammad.shafiq@rmi.edu.pk |
| Rahman U Jan, MCPS | Contact | +92-3339749567 | janrahman21@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad Shafiq, FCPS | Rehman Medical institute, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehman Medical Institute | Recruiting | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11871952 | Background | 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. | |
| 23991600 | Result | 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. |
Not provided
Not provided
Yes Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.
April, 2022 to April, 2025
IPD will be shared on inter institutional request basis.
Not provided
Not provided
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001591 | Benzydamine |
| D036881 | Long-Term Synaptic Depression |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Parallel Assignment The study design is prospective double-blinded randomized controlled parallel trial with allocation ratio of 1:1.
Not provided
Not provided
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.
|
| Aspirin | Drug | 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 |
|
|
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 |
| 27158989 | Result | 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. |
| 22066487 | Result | 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. |
| 22174478 | Result | 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. |
| Result | 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. |
| 24263969 | Result | 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. |
| 17000820 | Result | 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. |
| 26470672 | Result | 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. |
| 26171894 | Result | 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. |
| 30617677 | Result | 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. |
| 32247315 | Result | 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. |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |