S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat
- Conditions
- Sore Throat
- Interventions
- Registration Number
- NCT02608788
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- intubation for patients under general anesthesia
- age>20
- none pre-operative sore throat
- by the researchers explain research purposes, the researchers agreed to participate
- postoperative on N-G tube
- Surgical side is located by the mouth or throat
- thyroidectomy
- difficult airway
- none extubation at PACU
- on patient-controlled analgesia
- the medical records have a history of nonsteroidal antiinflammatory drugs allergy
- medical records have kidney disease or a history of renal dysfunction
- peptic ulcer
- pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acular® & S.L.® Acular® "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. S.L.® & Difflam Forte ® S.L.® "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. placebo ( for Acular® ) placebo 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. Difflam Forte ® & Acular® Difflam Forte ® "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.
- Primary Outcome Measures
Name Time Method pain scale (Numeric Rating Scale: 0-10) 1.5 year
- Secondary Outcome Measures
Name Time Method nonsteroidal antiinflammatory drug side effect 1.5 year