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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02608788
Other study ID # 103-2453A3
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date July 2015

Study information

Verified date October 2015
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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: 1. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. 2. Acular spray for the prevention of postoperative sore throat. 3. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.


Description:

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, 5ï¼…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: 1. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. 2. Acular spray for the prevention of postoperative sore throat. 3. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.


Recruitment information / eligibility

Status Completed
Enrollment 380
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: 1. intubation for patients under general anesthesia 2. age>20 3. none pre-operative sore throat 4. by the researchers explain research purposes, the researchers agreed to participate Exclusion Criteria: 1. postoperative on N-G tube 2. Surgical side is located by the mouth or throat 3. thyroidectomy 4. difficult airway 5. none extubation at PACU 6. on patient-controlled analgesia 7. the medical records have a history of nonsteroidal antiinflammatory drugs allergy 8. medical records have kidney disease or a history of renal dysfunction 9. peptic ulcer 10. pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
S.L.®
"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.
Difflam Forte ®
"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.
Acular®
"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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

References & Publications (1)

Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, Lee MS, Cherng CH. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010 Oct;111(4):882-6. doi: 10.1213/ANE.0b013e3181d4854e. Epub 2010 Mar 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain scale (Numeric Rating Scale: 0-10) 1.5 year
Secondary nonsteroidal antiinflammatory drug side effect 1.5 year
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