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Completed

NCT Number: NCT02608788

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Andolex®

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.

Other names: Tantum Verde®

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.

Other names: Apo-Ketorolac® Ophthalmic

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.

Other names: distilled water

Primary outcomes

  1. pain scale (Numeric Rating Scale: 0-10)

    Time frame: 1.5 year

Secondary outcomes

  1. nonsteroidal antiinflammatory drug side effect

    Time frame: 1.5 year

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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