The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Anesthesia Intubation Complication Clinical Trial

Official title:

The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039427
• Other study ID #: YUH-3368-sore throat
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: December 28, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Pharyngitis
• Tracheal Disease
• Tracheal Diseases

Intervention

Drug:
• Ketorolac
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml

Other:
• Dexamethasone
dexamethasone acetate10 mg : total volume of 2 ml

Drug:
• Placebo
Normal saline 2 ml

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of sore throat	mild (less severe than with a cold); moderate (similar with a cold); 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.	up to 24 hours after surgery	No
Secondary	incidence and severity of hoarseness	Hoarseness scale 0-3 0 none; mild (noted by the patient only); severe (noticed by the time of the interview by the observer); aphonia (silence of voice); incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign	1. 1h after surgery, 2. 6h after surgery, 3. 24h after surgery	No

External Links

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