N/A N=192 Randomized Quadruple-blind Prevention

The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Anesthesia Intubation Complication · Tracheal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02039427 ↗

Enrolled (actual)

192

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy — 43; 44; 42; 41 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ketorolac (Drug); Dexamethasone (Other); Placebo (Drug)
Age: Adult · 20+ yrs
Sex: Female
Sponsor: Yeungnam University College of Medicine
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy	43; 44; 42; 41; 32; 34	—
SECONDARY The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy	42; 44; 40; 40; 37; 36	—

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

Eligibility Criteria

Inclusion Criteria

American society of Anesthesiologists(ASA) physical status 1 and 2
20-60 years old female
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

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Data sourced from ClinicalTrials.gov (NCT02039427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.