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S.L. Spray Solution® and Difflam® and 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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608788
Enrollment
380
Registered
2015-11-20
Start date
2014-09-30
Completion date
2015-07-31
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore Throat

Keywords

postoperative sore throat, American Society of Anesthesiologists status, general anesthesia, post-anesthesia care unit(PACU)

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.

Interventions

DRUGS.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.

DRUGDifflam 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.

DRUGAcular®

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.

DRUGplacebo

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
pain scale (Numeric Rating Scale: 0-10)1.5 year

Secondary

MeasureTime frame
nonsteroidal antiinflammatory drug side effect1.5 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026