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
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Condition or disease | Intervention/treatment | Phase |
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For Intervention | Drug: benzydamine HCl | Phase 3 |
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 |
Arm | Intervention/treatment |
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No Intervention: nothing
nothing will be dripped on the cuff of the endotracheal tube in the control group
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Experimental: benzydamine HCl
benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia
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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 |
- analgesic effect [ Time Frame: 24 hours ]evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
Principal Investigator: | Sasikaan - Nimmaanrat, MD | Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand |
Responsible Party: | Sasikaan Nimmaanrat, Associate Professor, Prince of Songkla University |
ClinicalTrials.gov Identifier: | NCT01637883 |
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 |
benzydamine HCl endotracheal tube postoperative sore throat |
Pharyngitis Respiratory Tract Infections Infections Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Diseases Otorhinolaryngologic Diseases Benzydamine Anti-Inflammatory Agents |