S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat

Study Overview
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Brief Summary
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The purpose of intubation for patients under general anesthesia is to maintain their respiratory function. However, this procedure does cause a postoperative sore throat. Comfort of patients could be promoted if effective treatment could be found. The specific aims of this project are: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. Acular spray for the prevention of postoperative sore throat. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.

Detailed Description
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This is a quasi-experimental study with purposive sampling. Patients were distributed into the four groups (1.5mg / ml Benzydamine hydrochloride, 3.0mg / ml Benzydamine hydrochloride, 5％Ketorolac Tromethamine) by the operative room. Research tools including pain scale (Numeric Rating Scale: 0-10), drugs and case data record sheet. Collected information was managed by SPSS for Windows (version 21.0) statistical software package. Both the descriptive and Inferential statistics were performed. Sample homogeneity among the four groups were verified by F-test and chi-square test. generalized estimating equation was selected to compare the throat pain in the four points of assessment. The specific aims of this project are: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. Acular spray for the prevention of postoperative sore throat. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.

Official Title
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Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat

Conditions
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Sore Throat

Intervention / Treatment
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* Drug: S.L.®
* Drug: Difflam Forte ®
* Drug: Acular®
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intubation for patients under general anesthesia age>20 none pre-operative sore throat by the researchers explain research purposes, the researchers agreed to participate Exclusion Criteria: postoperative on N-G tube Surgical side is located by the mouth or throat thyroidectomy difficult airway none extubation at PACU on patient-controlled analgesia the medical records have a history of nonsteroidal antiinflammatory drugs allergy medical records have kidney disease or a history of renal dysfunction peptic ulcer pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S.L.® & Difflam Forte ®<br>1.5 mg/ml Benzydamine , S.L.® Spray Solution 2.5 mg and 3.0 mg/ml Benzydamine ,Difflam Forte ® 5.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff. | Drug: S.L.®<br>* 1.5mg/ml Benzydamine hydrochloride, S.L.® spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.<br>* Other names: Andolex®;|
| Placebo Comparator: placebo ( for Acular® )<br>placebo(distilled water)spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff. | Drug: placebo<br>* Distilled water spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.<br>* Other names: distilled water;|
| Active Comparator: Acular® & S.L.®<br>5％ Ketorolac Tromethamine , Acular® 8.0 mg and 1.5 mg/ml Benzydamine , S.L.® Spray Solution 2.5 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff. | Drug: Acular®<br>* 5％ Ketorolac Tromethamine ,  Acular®  spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.<br>* Other names: Apo-Ketorolac® Ophthalmic;|
| Experimental: Difflam Forte ® & Acular®<br>3.0 mg/ml Benzydamine , Difflam Forte ® 5.0 mg and 5％ Ketorolac Tromethamine Acular® 8.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff. | Drug: Difflam Forte ®<br>* 3.0mg/ml Benzydamine hydrochloride ,  Difflam Forte ® spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.<br>* Other names: Tantum Verde®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scale (Numeric Rating Scale: 0-10) |  | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nonsteroidal antiinflammatory drug side effect |  | 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative sore throat, American Society of Anesthesiologists status, general anesthesia, post-anesthesia care unit(PACU)