For Intervention Clinical Trial
— POSTOfficial title:
Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
Verified date | July 2012 |
Source | Prince of Songkla University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Prince of Songkla University | Hatyai | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
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 |