The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

NCT02039427 | Completed Results DMC

• 1 other identifier: YUH-3368-sore throat
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia Intubation Complication; Tracheal Disease

Keywords

Sore throat; Hoarseness; Intubation; Thyroidectomy; Ketorolac; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy

  at 1, 6 and 24 hours after thyroidectomy

Other Outcomes (1)

• Potential Side Effects Associated With the Study Drugs

  at 1, 6 and 24 hours after extubation

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Preketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Postketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Dexamethasone

ACTIVE COMPARATOR

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

Other: Dexamethasone

Interventions

Ketorolac DRUG

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

Also known as: Kerola

Postketorolac; Preketorolac

Dexamethasone OTHER

dexamethasone acetate10 mg : total volume of 2 ml

Dexamethasone

Placebo DRUG

Normal saline 2 ml

Also known as: control

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American society of Anesthesiologists(ASA) physical status 1 and 2
• years old female
• elective scheduled thyroidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Related 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

MeSH Terms

Conditions

Tracheal Diseases; Pharyngitis; Hoarseness

Interventions

Ketorolac; Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Laryngeal Diseases; Respiration Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The present study has some limitations. First, the dose of dexamethasone and ketorolac may not be equipotent in terms of anti-inflammatory efficacy. Second, postoperative pain control might affect the incidence and severity of the POST.

Results Point of Contact

• Title: Sung Mee Jung, M.D
• Organization: Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea

applejsm@gmail.com

+82-53-620-3368

Study Officials

• Sung Mee Jung, M.D.

  Yeungnam University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 28, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07

Locations

KR (1)