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The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02039427
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : July 31, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Sung Mee Jung, Yeungnam University College of Medicine

Tracking Information
First Submitted Date  ICMJE January 15, 2014
First Posted Date  ICMJE January 17, 2014
Results First Submitted Date  ICMJE December 7, 2016
Results First Posted Date  ICMJE July 31, 2017
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
incidence and severity of sore throat [ Time Frame: up to 24 hours after surgery ]
<Sore throat scale> 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
The Incidence of Postoperative Hoarseness(PH) 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. 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
incidence and severity of Hoarsenss [ Time Frame: 1. 1h after surgery, 2. 6h after surgery, 3. 24h after surgery ]
Hoarseness scale 0-3 0 none
  1. mild (noted by the patient only)
  2. severe (noticed by the time of the interview by the observer)
  3. aphonia (silence of voice)
incidence of hoarsenss: If patient exhibit hoarsenss scale more than 1, investigator will record as positive sign
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2017)
Potential Side Effects Associated With the Study Drugs [ Time Frame: at 1, 6 and 24 hours after extubation ]
Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Official Title  ICMJE The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Anesthesia Intubation Complication
  • Tracheal Disease
Intervention  ICMJE
  • Drug: Ketorolac
    ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
    Other Name: Kerola
  • Other: Dexamethasone
    dexamethasone acetate10 mg : total volume of 2 ml
  • Drug: Placebo
    Normal saline 2 ml
    Other Name: control
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
    Intervention: Drug: Placebo
  • Active Comparator: Preketorolac
    Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
    Intervention: Drug: Ketorolac
  • Active Comparator: Postketorolac
    Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
    Intervention: Drug: Ketorolac
  • Active Comparator: Dexamethasone
    Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
    Intervention: Other: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2015)
192
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2014)
120
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02039427
Other Study ID Numbers  ICMJE YUH-3368-sore throat
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sung Mee Jung, Yeungnam University College of Medicine
Study Sponsor  ICMJE Yeungnam University College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sung Mee Jung, M.D. Yeungnam University College of Medicine
PRS Account Yeungnam University College of Medicine
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP