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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Sore Throat

Treatments: Drug: S.L.®; Drug: Difflam Forte ®; Drug: Acular®; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02608788

103-2453A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 4 patient groups, including a placebo group

S.L.® & Difflam Forte ®

Active Comparator group

Description:

"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.

Treatment:

Drug: S.L.®

placebo ( for Acular® )

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

Acular® & S.L.®

Active Comparator group

Description:

"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.

Treatment:

Drug: Acular®

Difflam Forte ® & Acular®

Experimental group

Description:

"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.

Treatment:

Drug: Difflam Forte ®