The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Yeungnam University College of Medicine

Status: Completed

Conditions: Tracheal Disease; Anesthesia Intubation Complication

Treatments: Drug: Placebo; Other: Dexamethasone; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT02039427

YUH-3368-sore throat

Details and patient eligibility

About

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

Full 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.

Enrollment: 192 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Preketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac

Postketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac

Dexamethasone

Active Comparator group

Description:

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

Treatment:

Other: Dexamethasone