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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

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.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: S.L.® Drug: Difflam Forte ® Drug: Acular® Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
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.
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®

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.
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

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.
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

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.
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®




Primary Outcome Measures :
  1. pain scale (Numeric Rating Scale: 0-10) [ Time Frame: 1.5 year ]

Secondary Outcome Measures :
  1. nonsteroidal antiinflammatory drug side effect [ Time Frame: 1.5 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608788


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Hsiu-Ling Yang, RN, MS Chang Gung Memorial Hospital

Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02608788    
Other Study ID Numbers: 103-2453A3
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: October 2015
Keywords provided by Chang Gung Memorial Hospital:
postoperative sore throat
American Society of Anesthesiologists status
general anesthesia
post-anesthesia care unit(PACU)
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ketorolac
Ketorolac Tromethamine
Benzydamine
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action