Benzydamine HCl for Postoperative Sore Throat (POST)

July 25, 2012 updated by: Sasikaan Nimmaanrat, Prince of Songkla University

Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat

To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hatyai, Songkhla, Thailand, 90110
        • Recruiting
        • Faculty of Medicine, Prince of Songkla University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sasikaan - Nimmaanrat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-65 years
  • ASA status I-II
  • Mallampati grade I-II
  • Duration of surgery less than 4 hours
  • Patients placed in the supine position

Exclusion Criteria:

  • Undergoing oral, cervical spine or thyroid surgery
  • More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure
  • Insertion of nasogastric/orogastric tube or esophageal stethoscope
  • Complaint of sore throat or hoarseness
  • Presence of upper respiratory tract infection within 7 days prior to the operation
  • Gastroesophageal reflux
  • Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: nothing
nothing will be dripped on the cuff of the endotracheal tube in the control group
Experimental: benzydamine HCl
benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia
Drug: benzydamine HCl
3 ml (4.5 mg) of benzydamine hydrochloride will be dripped on the cuff of the endotracheal tube 5 minutes prior to induction of general anesthesia
Other Names:
  • Difflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic effect
Time Frame: 24 hours
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects of benzydamine hydrochloride
Time Frame: 24 hours
the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Sasikaan - Nimmaanrat, MD, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

July 7, 2012

First Submitted That Met QC Criteria

July 7, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54-039-08-1-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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