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Benzydamine HCl for Postoperative Sore Throat (POST)

This study is currently recruiting participants.
Verified July 2012 by Prince of Songkla University
Sponsor:
Information provided by (Responsible Party):
Sasikaan Nimmaanrat, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01637883
First received: July 7, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
For Intervention
 Drug: benzydamine HCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • analgesic effect [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation


Estimated Enrollment: 86
Study Start Date: January 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Difflam

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637883

Locations
Thailand
Faculty of Medicine, Prince of Songkla University Recruiting
Hatyai, Songkhla, Thailand, 90110
Contact: Sasikaan - Nimmaanrat, MD     +6674455000 ext 1651     snimmaanrat@yahoo.com.au    
Contact: Kadesirin - Chokkijchai     +6674455000 ext 1652     kadesirin@hotmail.com    
Principal Investigator: Sasikaan - Nimmaanrat            
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Sasikaan - Nimmaanrat, MD Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
  More Information

No publications provided

Responsible Party: Sasikaan Nimmaanrat, Associate Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01637883     History of Changes
Other Study ID Numbers: 54-039-08-1-2
Study First Received: July 7, 2012
Last Updated: July 25, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
benzydamine HCl
endotracheal tube
postoperative sore throat

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Benzydamine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013