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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery |
|
| Preketorolac | Active Comparator | Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery |
|
| Postketorolac | Active Comparator | Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery |
|
| Dexamethasone | Active Comparator | Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1, 6 and 24 hours after thyroidectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Potential Side Effects Associated With the Study Drugs | Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting. | at 1, 6 and 24 hours after extubation |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Sung Mee Jung, M.D. | Yeungnam University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Daegu | 705-717 | South Korea |
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| Label | URL |
|---|---|
| Complaints of sore throat after tracheal intubation: a prospective evaluation | View source |
| Gender differences in risk factors for airway symptoms following tracheal intubation | View source |
| Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trials |
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Patients with a airway problem, recent upper respiratory tract infection, obese, inflammation or hemorrhage in the upper gastrointestinal tract, use of NSAID or steroid medication, allergy to the general anesthetic used in this study were excluded.
This study was conducted Yeungnam University Hospital in South korea from Oct. 2013 to Oct. 2015. One hundred and ninety - two female adults aged between 20 and 65 years, ASA physical status I or II scheduled for elective primary thyroidectomy under general anesthesia were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Placebo: Normal saline 2 ml |
| FG001 | Preketorolac | Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| FG002 | Postketorolac | Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| FG003 | Dexamethasone | Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery Placebo: Normal saline 2 ml |
| BG001 | Preketorolac | Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | at 1, 6 and 24 hours after thyroidectomy |
|
1h, 6h and 24h after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery Placebo: Normal saline 2 ml |
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The present study has some limitations. First, the dose of dexamethasone and ketorolac may not be equipotent in terms of anti-inflammatory efficacy. Second, postoperative pain control might affect the incidence and severity of the POST.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sung Mee Jung, M.D | Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea | +82-53-620-3368 | applejsm@gmail.com |
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| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D010612 | Pharyngitis |
| D006685 | Hoarseness |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Dexamethasone | Other | dexamethasone acetate10 mg : total volume of 2 ml |
|
| Placebo | Drug | Normal saline 2 ml |
|
|
| at 1, 6 and 24 hours after thyroidectomy |
| View source |
| Withdrawal on concent |
|
| Cancellation of surgery |
|
| Loss of follow - up |
|
| Steroid Use |
|
| BG002 | Postketorolac | Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| BG003 | Dexamethasone | Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Preketorolac |
Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| OG002 | Postketorolac | Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
| OG003 | Dexamethasone | Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | at 1, 6 and 24 hours after thyroidectomy |
|
|
|
| Other Pre-specified | Potential Side Effects Associated With the Study Drugs | Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting. | Posted | Count of Participants | Participants | at 1, 6 and 24 hours after extubation |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Preketorolac | Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml | 0 | 47 | 0 | 47 | 0 | 47 |
| EG002 | Postketorolac | Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml | 0 | 45 | 0 | 45 | 0 | 45 |
| EG003 | Dexamethasone | Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml | 0 | 43 | 0 | 43 | 0 | 43 |
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| D009057 |
| Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012120 | Respiration Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Hoarseness at 6h |
|
| Hoarseness at 24h |
|
| Analgesic use at 6h |
|
| Analgesic use at 24h |
|
| Nausea at 1h |
|
| Nausea at 6h |
|
| Nausea at 24h |
|
| Vomiting at 1h |
|
| Vomiting at 6h |
|
| Vomiting at 24h |
|