The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.

NCT04412694

Hypocalcemia Vitamin D Deficiency Postoperative Complications +4 more

UNKNOWN PHASE4

2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

NCT04268407

Thyroid Nodule

COMPLETED NA

Steroid Before Thyroidectomy

NCT00619086

Thyroid Surgery for Benign Disease

COMPLETED NA

Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy

NCT03295955

Surgical Wound Infection Thyroid Nodule

UNKNOWN NA

Nausea and Pain Prophylaxis During Thyroid Surgery

NCT00569920

Thyroid Diseases Parathyroid Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Intubation Complication Tracheal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline 2 ml

Preketorolac

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

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

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

Postketorolac

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

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

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

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type OTHER

dexamethasone acetate10 mg : total volume of 2 ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac

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

Intervention Type DRUG

Dexamethasone

dexamethasone acetate10 mg : total volume of 2 ml

Intervention Type OTHER

Placebo

Normal saline 2 ml

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kerola control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No