The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
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ClinicalTrials.gov Identifier: NCT02039427 |
Recruitment Status :
Completed
First Posted : January 17, 2014
Results First Posted : July 31, 2017
Last Update Posted : August 28, 2017
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Anesthesia Intubation Complication Tracheal Disease |
Interventions |
Drug: Ketorolac Other: Dexamethasone Drug: Placebo |
Enrollment | 192 |
Recruitment Details | This study was conducted Yeungnam University Hospital in South korea from Oct. 2013 to Oct. 2015. One hundred and ninety - two female adults aged between 20 and 65 years, ASA physical status I or II scheduled for elective primary thyroidectomy under general anesthesia were enrolled. |
Pre-assignment Details | Patients with a airway problem, recent upper respiratory tract infection, obese, inflammation or hemorrhage in the upper gastrointestinal tract, use of NSAID or steroid medication, allergy to the general anesthetic used in this study were excluded. |
Arm/Group Title | Placebo | Preketorolac | Postketorolac | Dexamethasone |
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Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Placebo: Normal saline 2 ml |
Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml |
Period Title: Overall Study | ||||
Started | 48 | 48 | 48 | 48 |
Completed | 45 | 47 | 45 | 43 |
Not Completed | 3 | 1 | 3 | 5 |
Reason Not Completed | ||||
Duration of surgery > 3h | 1 | 1 | 0 | 0 |
Withdrawal on concent | 0 | 0 | 0 | 1 |
Cancellation of surgery | 0 | 0 | 1 | 0 |
Loss of follow - up | 1 | 0 | 2 | 4 |
Steroid Use | 1 | 0 | 0 | 0 |
Arm/Group Title | Placebo | Preketorolac | Postketorolac | Dexamethasone | Total | |
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Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery Placebo: Normal saline 2 ml |
Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml |
Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml |
Total of all reporting groups | |
Overall Number of Baseline Participants | 45 | 47 | 45 | 43 | 180 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 45 participants | 47 participants | 45 participants | 43 participants | 180 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
45 100.0%
|
47 100.0%
|
45 100.0%
|
43 100.0%
|
180 100.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 45 participants | 47 participants | 45 participants | 43 participants | 180 participants | |
48.2 (10.1) | 49.5 (9.2) | 47.3 (9.3) | 46.0 (11.1) | 47.8 (9.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 45 participants | 47 participants | 45 participants | 43 participants | 180 participants | |
Female |
45 100.0%
|
47 100.0%
|
45 100.0%
|
43 100.0%
|
180 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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0 0.0%
|
Name/Title: | Sung Mee Jung, M.D |
Organization: | Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea |
Phone: | +82-53-620-3368 |
EMail: | applejsm@gmail.com |
Responsible Party: | Sung Mee Jung, Yeungnam University College of Medicine |
ClinicalTrials.gov Identifier: | NCT02039427 |
Other Study ID Numbers: |
YUH-3368-sore throat |
First Submitted: | January 15, 2014 |
First Posted: | January 17, 2014 |
Results First Submitted: | December 7, 2016 |
Results First Posted: | July 31, 2017 |
Last Update Posted: | August 28, 2017 |