The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Conditions
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Anesthesia Intubation Complication, Tracheal Disease

Intervention / Treatment
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* Drug: Ketorolac
* Other: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of Anesthesiologists(ASA) physical status 1 and 2 20-60 years old female elective scheduled thyroidectomy 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery | Drug: Placebo<br>* Normal saline 2 ml<br>* Other names: control;|
| Active Comparator: Preketorolac<br>Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery | Drug: Ketorolac<br>* ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml<br>* Other names: Kerola;|
| Active Comparator: Postketorolac<br>Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery | Drug: Ketorolac<br>* ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml<br>* Other names: Kerola;|
| Active Comparator: Dexamethasone<br>Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery | Other: Dexamethasone<br>* dexamethasone acetate10 mg : total volume of 2 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | at 1, 6 and 24 hours after thyroidectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone