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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):
Sasikaan Nimmaanrat, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE July 7, 2012
First Posted Date  ICMJE July 11, 2012
Last Update Posted Date July 26, 2012
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
analgesic effect [ Time Frame: 24 hours ]
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2012)
analgesic effect [ Time Frame: 24 hours after the operation ]
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2012)
side effects of benzydamine hydrochloride [ Time Frame: 24 hours after the operation ]
the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benzydamine HCl for Postoperative Sore Throat
Official Title  ICMJE Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE For Intervention
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: benzydamine HCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2012)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01637883
Other Study ID Numbers  ICMJE 54-039-08-1-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sasikaan Nimmaanrat, Prince of Songkla University
Study Sponsor  ICMJE Prince of Songkla University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sasikaan - Nimmaanrat, MD Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
PRS Account Prince of Songkla University
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP