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

NCT ID: NCT02608788

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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.

Conditions

Sore Throat

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

S.L.® & Difflam Forte ®

"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.

Group Type: ACTIVE_COMPARATOR

S.L.®

Intervention Type: DRUG

"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.

placebo ( for Acular® )

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Acular® & S.L.®

"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.

Group Type: ACTIVE_COMPARATOR

Acular®

Intervention Type: DRUG

"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.

Difflam Forte ® & Acular®

"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.

Group Type: EXPERIMENTAL

Difflam Forte ®

Intervention Type: DRUG

"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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Andolex®; Tantum Verde®; Apo-Ketorolac® Ophthalmic; distilled water

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiu-Ling Yang, RN, MS

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

References

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.

Reference Type: BACKGROUND

PMID: 20304980 (View on PubMed)

Other Identifiers

103-2453A3

Identifier Type: -

Identifier Source: org_study_id