The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yeungnam University College of Medicine
Sponsor:
Information provided by (Responsible Party):
Sung Mee Jung, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier:
NCT02039427
First received: January 15, 2014
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Anesthesia Intubation Complication
Tracheal Disease
Drug: Ketorolac
Other: Dexamethasone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Resource links provided by NLM:


Further study details as provided by Yeungnam University College of Medicine:

Primary Outcome Measures:
  • incidence and severity of sore throat [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]

    <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.



Secondary Outcome Measures:
  • incidence and severity of hoarseness [ Time Frame: 1. 1h after surgery, 2. 6h after surgery, 3. 24h after surgery ] [ Designated as safety issue: No ]

    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 hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign



Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Drug: Placebo
Normal saline 2 ml
Other Name: control
Active Comparator: Preketorolac
Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Drug: Ketorolac
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
Other Name: Kerola
Active Comparator: Postketorolac
Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Drug: Ketorolac
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
Other Name: Kerola
Active Comparator: Dexamethasone
Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Other: Dexamethasone
dexamethasone acetate10 mg : total volume of 2 ml

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039427

Contacts
Contact: Sung Mee Jung, M.D. +82-53-620-3368 applejsm@gmail.com

Locations
Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Sung Mee Jung, M.D.    +82-53-620--3368      
Principal Investigator: Sung Mee Jung, M.D.         
Sponsors and Collaborators
Yeungnam University College of Medicine
Investigators
Principal Investigator: Sung Mee Jung, M.D. Yeungnam University College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Sung Mee Jung, M.D., Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT02039427     History of Changes
Other Study ID Numbers: YUH-3368-sore throat
Study First Received: January 15, 2014
Last Updated: January 17, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Yeungnam University College of Medicine:
Sore throat
Hoarseness
Intubation
Thyroidectomy
Ketorolac
Dexamethasone

Additional relevant MeSH terms:
Pharyngitis
Tracheal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Ketorolac
Ketorolac Tromethamine
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014