Sore ThroatPhase 4NCT02682134
Sore Throat Prevention Following Intubation
A Phase 4 study testing xylocaine, Dexamethasone and Xylocaine and Dexamethasone in people with Sore Throat, run by University of Jordan.
Trial summary
The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- xylocaine, Dexamethasone and Xylocaine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Feb 2016
- Phase
- Phase 4
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA 1-3.
- Elective VS Emergency.
- Cuffed endo-tracheal tubes.
- Different types of surgery.
Who cannot join
- Pregnant ladies.
- ICU patients.
- <15 years of age
- Laryngeal mask airway
About this study
Official title: Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study
The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.
Read the detailed description
Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).
The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.
- Conditions
- Sore Throat
- Being tested
- xylocaine, Dexamethasone, Xylocaine and Dexamethasone
- Keywords
- Sore Throat, Intubation, Xylocaine, Dexamethasone
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylocaineDrug
Also called X
First group were given xylocaine
DexamethasoneDrug
Also called D
Second group were given Dexamethasone
Xylocaine and DexamethasoneDrug
Also called XD
Third group were given both Xylocaine and Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine "X" | Experimental | Patients received xylocaine gel as lubricant on endotracheal tube Receives: Drug: xylocaine |
| Dexamethasone "D" | Experimental | Patients were given dexamethasone 8 mg intravenously Receives: Drug: Dexamethasone |
| xylocaine and dexamethasone "XD" | Experimental | Patients were given both xylocaine gel and dexamethasone 8 mg intravenously Receives: Drug: Xylocaine and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
Questionnaire follow up in intubated patients.
Measured: 4 months
Secondary outcomes (1)
Sore throat SCALE
Sore throat scale from None,mild,moderate till severe.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aboud Nayef AlJabari, University of Jordan
- Investigators
- Aboud Aljabari, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682134
- Sponsor's protocol ID
- AAlJabari
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study
- ClinicalTrials.gov ID
- NCT02682134
- Acronym / sponsor ID
- AAlJabari
- Conditions
- Sore Throat
- Keywords
- Sore Throat, Intubation, Xylocaine, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Feb 2016 (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 aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.
Detailed description
Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).
The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xylocaine "X" | Experimental | Drug: xylocainePatients received xylocaine gel as lubricant on endotracheal tube |
| Dexamethasone "D" | Experimental | Drug: DexamethasonePatients were given dexamethasone 8 mg intravenously |
| xylocaine and dexamethasone "XD" | Experimental | Drug: Xylocaine and DexamethasonePatients were given both xylocaine gel and dexamethasone 8 mg intravenously |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1-3.
- Elective VS Emergency.
- Cuffed endo-tracheal tubes.
- Different types of surgery.
Key exclusion criteria (4 listed)
- Pregnant ladies.
- ICU patients.
- <15 years of age
- Laryngeal mask airway
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 |
|---|---|---|
| xylocaineAlso: XFirst group were given xylocaine | Drug | Xylocaine "X" |
| DexamethasoneAlso: DSecond group were given Dexamethasone | Drug | Dexamethasone "D" |
| Xylocaine and DexamethasoneAlso: XDThird group were given both Xylocaine and Dexamethasone | Drug | xylocaine and dexamethasone "XD" |
Primary outcome
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
Time frame: 4 months
Questionnaire follow up in intubated patients.
1 secondary outcome
Sore throat SCALE
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Aboud Aljabari principal investigator
University of Jordan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing xylocaine, Dexamethasone and Xylocaine and Dexamethasone in people with Sore Throat, run by University of Jordan.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation. (time frame: 4 months). 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 15 Feb 2016.