Anesthesia Intubation ComplicationNCT02039427
The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
A study testing Ketorolac and Dexamethasone in people with Anesthesia Intubation Complication and Tracheal Disease, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
Sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. Although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Anesthesia Intubation Complication, Tracheal Disease
- What is being tested?
- Ketorolac and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American society of Anesthesiologists(ASA) physical status 1 and 2
- 20-60 years old female
- elective scheduled thyroidectomy
Who cannot join
- surgery longer than 3 hours Previous history of or expected difficult tracheal intubation Laryngoscope grade (by Cormack and Lehane) of 3 or 4 2 more trial for intubation BMI > 30 Hypersensitivity to ketorolac history of asthma respiratory tract infection during the past 6 weeks Renal dysfunction (creatinine > 1.5 mg/dl or oligouria) Hepatic dysfunction (ALT :> 50% more than normal value) Use of corticosteroid, NSAIDS, angiotensin converting enzyme in 10 days Medication for gastritis, gastric ulcer Upper gastrointestinal bleeding history Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. Although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative recovery and give patient dissatisfaction.
Even though the pathophysiology of post-intubation airway symptoms is not completely clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly used strategy to prevent postoperative airway discomfort after intubation. The preoperative administration of dexamethasone has been reported to reduce the incidence and severity of postoperative sore throat, but it is accompanied with the adverse effects such as hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac, non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for postoperative pain control and has anti-inflammatory effect.
Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in comparison to dexamethasone after thyroidectomy in female adult patients
Read the detailed description
Ketorolac, NSAID, has not been evaluated as a pharmacologic strategy to reduce postoperative sore throat yet. The investigator will explore how the analgesic and anti-inflammatory effects of ketorolac influence airway symptoms following general anesthesia with tracheal intubation.
- Being tested
- Ketorolac, Dexamethasone, Placebo
- Keywords
- Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone
- Medical subject headings
- Tracheal Diseases, Pharyngitis, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Kerola
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
DexamethasoneOther
dexamethasone acetate10 mg : total volume of 2 ml
PlaceboDrug
Also called control
Normal saline 2 ml
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery Receives: Drug: Placebo |
| Preketorolac | Active comparator | Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery Receives: Drug: Ketorolac |
| Postketorolac | Active comparator | Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery Receives: Drug: Ketorolac |
| Dexamethasone | Active comparator | Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery Receives: Other: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0-3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold)
● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom.
Measured: at 1, 6 and 24 hours after thyroidectomy
Secondary outcomes (1)
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0-3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice)
● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign
Measured: at 1, 6 and 24 hours after thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia Intubation ComplicationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Mee Jung, Yeungnam University College of Medicine
- Investigators
- Sung Mee Jung, M.D., Principal investigator, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039427
- Sponsor's protocol ID
- YUH-3368-sore throat
- Status last verified
- Jul 2017
- First submitted
- 15 Jan 2014
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02039427
- Acronym / sponsor ID
- YUH-3368-sore throat
- Keywords
- Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. Although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative recovery and give patient dissatisfaction.
Even though the pathophysiology of post-intubation airway symptoms is not completely clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly used strategy to prevent postoperative airway discomfort after intubation. The preoperative administration of dexamethasone has been reported to reduce the incidence and severity of postoperative sore throat, but it is accompanied with the adverse effects such as hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac, non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for postoperative pain control and has anti-inflammatory effect.
Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in comparison to dexamethasone after thyroidectomy in female adult patients
Detailed description
Ketorolac, NSAID, has not been evaluated as a pharmacologic strategy to reduce postoperative sore throat yet. The investigator will explore how the analgesic and anti-inflammatory effects of ketorolac influence airway symptoms following general anesthesia with tracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery |
| Preketorolac | Active comparator | Drug: KetorolacKetorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery |
| Postketorolac | Active comparator | Drug: KetorolacNormal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery |
| Dexamethasone | Active comparator | Other: DexamethasoneDexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American society of Anesthesiologists(ASA) physical status 1 and 2
- 20-60 years old female
- elective scheduled thyroidectomy
Key exclusion criteria (1 listed)
- surgery longer than 3 hours Previous history of or expected difficult tracheal intubation Laryngoscope grade (by Cormack and Lehane) of 3 or 4 2 more trial for intubation BMI > 30 Hypersensitivity to ketorolac history of asthma respiratory tract infection during the past 6 weeks Renal dysfunction (creatinine > 1.5 mg/dl or oligouria) Hepatic dysfunction (ALT :> 50% more than normal value) Use of corticosteroid, NSAIDS, angiotensin converting enzyme in 10 days Medication for gastritis, gastric ulcer Upper gastrointestinal bleeding history Diabetes mellitus
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 |
|---|---|---|
| KetorolacAlso: Kerolaketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml | Drug | Postketorolac, Preketorolac |
| Dexamethasonedexamethasone acetate10 mg : total volume of 2 ml | Other | Dexamethasone |
| PlaceboAlso: controlNormal saline 2 ml | Drug | Placebo |
Primary outcome
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Time frame: at 1, 6 and 24 hours after thyroidectomy
The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0-3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold) ● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom.
1 secondary outcome
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Time frame: at 1, 6 and 24 hours after thyroidectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Complaints of sore throat after tracheal intubation: a prospective evaluationLink provided by the sponsor.
- Gender differences in risk factors for airway symptoms following tracheal intubationLink provided by the sponsor.
- Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trialsLink provided by the sponsor.
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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.
Sung Mee Jung, M.D. principal investigator
Yeungnam University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac and Dexamethasone in people with Anesthesia Intubation Complication and Tracheal Disease, run by Yeungnam University College of Medicine 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 3 inclusion and 1 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 28 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy (time frame: at 1, 6 and 24 hours after thyroidectomy). 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 28 Aug 2017.