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

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608788
• Other study ID #: 103-2453A3
• Status: Completed
• Phase: Phase 4
• 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
• 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, 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:

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

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

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