Benzydamine HCl for Postoperative Sore Throat

For Intervention Clinical Trial

— POST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01637883
• Other study ID #: 54-039-08-1-2
• Status: Recruiting
• Phase: Phase 3
• First received: July 7, 2012
• Last updated: July 25, 2012
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2012
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• For Intervention
• Pharyngitis

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic effect	evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation	24 hours	Yes
Secondary	side effects of benzydamine hydrochloride	the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation	24 hours	Yes