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

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ClinicalTrials.gov Identifier: NCT02608788
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE October 16, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
pain scale (Numeric Rating Scale: 0-10) [ Time Frame: 1.5 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
nonsteroidal antiinflammatory drug side effect [ Time Frame: 1.5 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat
Official Title  ICMJE Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Sore Throat
Intervention  ICMJE
  • Drug: 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.
    Other Name: Andolex®
  • 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.
    Other Name: Tantum Verde®
  • 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.
    Other Name: Apo-Ketorolac® Ophthalmic
  • 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.
    Other Name: distilled water
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: S.L.®
  • Placebo Comparator: 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.
    Intervention: Drug: placebo
  • Active Comparator: 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.
    Intervention: Drug: Acular®
  • Experimental: 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.
    Intervention: Drug: Difflam Forte ®
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2015)
380
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608788
Other Study ID Numbers  ICMJE 103-2453A3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hsiu-Ling Yang, RN, MS Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP