For InterventionPhase 3POSTNCT01637883
Benzydamine HCl for Postoperative Sore Throat
A Phase 3 study testing benzydamine HCl in people with For Intervention, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- For Intervention
- What is being tested?
- benzydamine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Sasikaan - Nimmaanrat, MD, +6674455000 ext. 1651, snimmaanrat@yahoo.com.au
Kadesirin - Chokkijchai, +6674455000 ext. 1652, kadesirin@hotmail.com
About this study
Official title: Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.
Read the 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.
- Conditions
- For Intervention
- Being tested
- benzydamine HCl
- Keywords
- benzydamine HCl, endotracheal tube, postoperative sore throat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzydamine HClDrug
Also called Difflam
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
| Study group | Role | What they receive |
|---|---|---|
| nothing | No intervention | nothing will be dripped on the cuff of the endotracheal tube in the control group |
| benzydamine HCl | Experimental | benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia Receives: Drug: benzydamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
Measured: 24 hours
Secondary outcomes (1)
side effects of benzydamine hydrochloride
the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for For InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
- Investigators
- Sasikaan - Nimmaanrat, MD, Principal investigator, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637883
- Sponsor's protocol ID
- 54-039-08-1-2
- Acronym
- POST
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT01637883
- Acronym / sponsor ID
- POST / 54-039-08-1-2
- Conditions
- For Intervention
- Keywords
- benzydamine HCl, endotracheal tube, postoperative sore throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nothing | No intervention | –nothing will be dripped on the cuff of the endotracheal tube in the control group |
| benzydamine HCl | Experimental | Drug: benzydamine HClbenzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzydamine HClAlso: Difflam3 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 | Drug | benzydamine HCl |
Primary outcome
analgesic effect
Time frame: 24 hours
evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation
1 secondary outcome
side effects of benzydamine hydrochloride
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Medicine, Prince of Songkla University
Hat Yai, Thailand
Sasikaan - Nimmaanrat, MD principal investigator
Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing benzydamine HCl in people with For Intervention, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic effect (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.