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

NCT02608788 | Completed Phase 4 DMC

• 1 other identifier: 103-2453A3
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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. 1.Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat.
2. 2.Acular spray for the prevention of postoperative sore throat.
3. 3.Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.

Conditions

Sore Throat

Keywords

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

Outcome Measures

Primary Outcomes (1)

• pain scale (Numeric Rating Scale: 0-10)

  1.5 year

Secondary Outcomes (1)

• nonsteroidal antiinflammatory drug side effect

  1.5 year

Study Arms (4)

S.L.® & Difflam Forte ®

ACTIVE COMPARATOR

"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.®

placebo ( for Acular® )

PLACEBO COMPARATOR

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

Acular® & S.L.®

ACTIVE COMPARATOR

"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®

Difflam Forte ® & Acular®

EXPERIMENTAL

"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 ®

Interventions

S.L.® DRUG

"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.

Also known as: Andolex®

S.L.® & Difflam Forte ®

Difflam Forte ® DRUG

"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.

Also known as: Tantum Verde®

Difflam Forte ® & Acular®

Acular® DRUG

"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.

Also known as: Apo-Ketorolac® Ophthalmic

Acular® & S.L.®

placebo DRUG

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.

Also known as: distilled water

placebo ( for Acular® )

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intubation for patients under general anesthesia
• age\>20
• none pre-operative sore throat
• by the researchers explain research purposes, the researchers agreed to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• 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.

  PMID: 20304980 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hsiu-Ling Yang, RN, MS

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 20, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 21, 2021

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share