PharyngitisNCT02252419
Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat
A study testing Dexamethasone and Paracetamol in people with Pharyngitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Dexamethasone and Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for urologic surgery under general anesthesia
- ASA I-III
Who cannot join
- Patients with recent sore throat
- Patients with neck surgery
- Patients with anticipated difficult airway
- Patients with Mallampati grade 3
- Patients with severe cardiovascular or pulmonary disease
- Patients with allergic history to dexamethasone or paracetamol
- Patients with liver function disorder
- Patients with liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seolu National University of Hospital
Seoul
Hyun-Chang Kim, MD, 83-10-2886-2876, onidori1979@gmail.com
About this study
Official title: Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.
Read the detailed description
The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.
- Conditions
- Pharyngitis
- Being tested
- Dexamethasone, Paracetamol
- Keywords
- Postoperative Period, Anesthesia, General, Intubation, Intratracheal, Dexamethasone, Acetaminophen
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone will be administered.
ParacetamolDrug
Paracetamol will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Dexamethasone will be administered 30 minutes before the anesthetic induction. Receives: Drug: Dexamethasone |
| Dexamethasone+ Paracetamol (DP) | Experimental | Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery. Receives: Drug: Dexamethasone; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat
Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
Measured: 1 hour postoperatively
Secondary outcomes (11)
Postoperative sore throat degree
Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
Measured: 0, 1, 6, 24 hour postoperatively
Postoperative pain
Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
Measured: 0, 1, 6, 24 hour postoperatively
Nausea
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Vomiting
Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Somnolence
Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Shivering
Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Headache
Headache will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Hoarseness
Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Dysphagia
Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Analgesics
Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.
Measured: 0, 1, 6, 24 hour postoperatively
Postoperative sore throat
Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
Measured: 0, 6, 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Pyoung Park, PhD, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252419
- Sponsor's protocol ID
- SoreThroatParacetamol
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery
- ClinicalTrials.gov ID
- NCT02252419
- Acronym / sponsor ID
- SoreThroatParacetamol
- Conditions
- Pharyngitis
- Keywords
- Postoperative Period, Anesthesia, General, Intubation, Intratracheal, Dexamethasone, Acetaminophen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 30 Sep 2014 (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.
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.
Detailed description
The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.
The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone will be administered 30 minutes before the anesthetic induction. |
| Dexamethasone+ Paracetamol (DP) | Experimental | Drug: Dexamethasone, Drug: ParacetamolDexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for urologic surgery under general anesthesia
- ASA I-III
Key exclusion criteria (8 listed)
- Patients with recent sore throat
- Patients with neck surgery
- Patients with anticipated difficult airway
- Patients with Mallampati grade 3
- Patients with severe cardiovascular or pulmonary disease
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 |
|---|---|---|
| DexamethasoneDexamethasone will be administered. | Drug | Dexamethasone, Dexamethasone+ Paracetamol (DP) |
| ParacetamolParacetamol will be administered. | Drug | Dexamethasone+ Paracetamol (DP) |
Primary outcome
Postoperative sore throat
Time frame: 1 hour postoperatively
Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
11 secondary outcomes
Postoperative sore throat degree
Time frame: 0, 1, 6, 24 hour postoperatively
Postoperative pain
Time frame: 0, 1, 6, 24 hour postoperatively
Nausea
Time frame: 0, 1, 6, 24 hour postoperatively
Vomiting
Time frame: 0, 1, 6, 24 hour postoperatively
Somnolence
Time frame: 0, 1, 6, 24 hour postoperatively
Shivering
Time frame: 0, 1, 6, 24 hour postoperatively
Headache
Time frame: 0, 1, 6, 24 hour postoperatively
Hoarseness
Time frame: 0, 1, 6, 24 hour postoperatively
Dysphagia
Time frame: 0, 1, 6, 24 hour postoperatively
Analgesics
Time frame: 0, 1, 6, 24 hour postoperatively
Postoperative sore throat
Time frame: 0, 6, 24 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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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.
Hee-Pyoung Park, PhD principal investigator
Seoul National University of Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Paracetamol in people with Pharyngitis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 8 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 17 Oct 2014. 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 South Korea. 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.
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?
Contact Hyun-Chang Kim, MD (82-10-2886-2876, onidori1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat (time frame: 1 hour postoperatively). 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 17 Oct 2014.