The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

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

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication; Tracheal Disease
• Intervention / Treatment: Drug: Placebo; Drug: Ketorolac; Other: Dexamethasone

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: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-717
    • Yeungnam University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine
• Investigators: Principal Investigator: Sung Mee Jung, M.D., Yeungnam University College of Medicine

Publications and helpful links

Helpful Links

• Complaints of sore throat after tracheal intubation: a prospective evaluation
• Gender differences in risk factors for airway symptoms following tracheal intubation
• Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trials

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Dexamethasone; Intubation; Thyroidectomy; Ketorolac; Sore throat; Hoarseness
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tracheal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Ketorolac
• Other Study ID Numbers: YUH-3368-sore throat