Clinical trial NCT02608788: S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat
Official title: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sore Throat
Keywords: postoperative sore throat
American Society of Anesthesiologists status
general anesthesia
post-anesthesia care unit(PACU)
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 380
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: pain scale (Numeric Rating Scale: 0-10)
timeFrame: 1.5 year
Secondary outcomes:
measure: nonsteroidal antiinflammatory drug side effect
timeFrame: 1.5 year
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsiu-Ling Yang, RN, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.