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Benzydamine HCl for Postoperative Sore Throat (POST)

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ClinicalTrials.gov Identifier: NCT01637883
Recruitment Status : Unknown
Verified July 2012 by Sasikaan Nimmaanrat, Prince of Songkla University.
Recruitment status was:  Recruiting
First Posted : July 11, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
For Intervention Drug: benzydamine HCl Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
Study Start Date : January 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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 Name: Difflam


Outcome Measures

Primary Outcome Measures :
  1. analgesic effect [ Time Frame: 24 hours ]
    evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012

Keywords provided by Sasikaan Nimmaanrat, 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