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The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Primary Purpose

Anesthesia Intubation Complication, Tracheal Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketorolac
Dexamethasone
Placebo
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia Intubation Complication focused on measuring Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. American society of Anesthesiologists(ASA) physical status 1 and 2
  2. 20-60 years old female
  3. 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

Sites / Locations

  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Preketorolac

Postketorolac

Dexamethasone

Arm Description

Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery

Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery

Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery

Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2014
Last Updated
July 30, 2017
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02039427
Brief Title
The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Official Title
The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complication, Tracheal Disease
Keywords
Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Arm Title
Preketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Arm Title
Postketorolac
Arm Type
Active Comparator
Arm Description
Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Kerola
Intervention Description
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
Intervention Type
Other
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone acetate10 mg : total volume of 2 ml
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
control
Intervention Description
Normal saline 2 ml
Primary Outcome Measure Information:
Title
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Description
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.
Time Frame
at 1, 6 and 24 hours after thyroidectomy
Secondary Outcome Measure Information:
Title
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Description
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
Time Frame
at 1, 6 and 24 hours after thyroidectomy
Other Pre-specified Outcome Measures:
Title
Potential Side Effects Associated With the Study Drugs
Description
Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.
Time Frame
at 1, 6 and 24 hours after extubation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Mee Jung, M.D.
Organizational Affiliation
Yeungnam University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/15892411
Description
Complaints of sore throat after tracheal intubation: a prospective evaluation
URL
http://www.ncbi.nlm.nih.gov/pubmed?linkname=pubmed_pubmed&from_uid=15892411
Description
Gender differences in risk factors for airway symptoms following tracheal intubation
URL
http://www.ncbi.nlm.nih.gov/pubmed/24357270
Description
Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trials

Learn more about this trial

The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

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