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Benzydamine HCl for Postoperative Sore Throat (POST)

Primary Purpose

For Intervention

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
benzydamine HCl
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for For Intervention focused on measuring benzydamine HCl, endotracheal tube, postoperative sore throat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Medicine, Prince of Songkla UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

nothing

benzydamine HCl

Arm Description

nothing will be dripped on the cuff of the endotracheal tube in the control group

benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia

Outcomes

Primary Outcome Measures

analgesic effect
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation

Secondary Outcome Measures

side effects of benzydamine hydrochloride
the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation

Full Information

First Posted
July 7, 2012
Last Updated
July 25, 2012
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01637883
Brief Title
Benzydamine HCl for Postoperative Sore Throat
Acronym
POST
Official Title
Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
For Intervention
Keywords
benzydamine HCl, endotracheal tube, postoperative sore throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nothing
Arm Type
No Intervention
Arm Description
nothing will be dripped on the cuff of the endotracheal tube in the control group
Arm Title
benzydamine HCl
Arm Type
Experimental
Arm Description
benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
benzydamine HCl
Other Intervention Name(s)
Difflam
Intervention Description
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
Primary Outcome Measure Information:
Title
analgesic effect
Description
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
side effects of benzydamine hydrochloride
Description
the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasikaan - Nimmaanrat, MD
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasikaan - Nimmaanrat, MD
Phone
+6674455000
Ext
1651
Email
snimmaanrat@yahoo.com.au
First Name & Middle Initial & Last Name & Degree
Kadesirin - Chokkijchai
Phone
+6674455000
Ext
1652
Email
kadesirin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sasikaan - Nimmaanrat

12. IPD Sharing Statement

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Benzydamine HCl for Postoperative Sore Throat

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