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Trial record 52 of 463 for:    KETOROLAC

The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02039427
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : July 31, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Sung Mee Jung, Yeungnam University College of Medicine

Study Type Interventional
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
Hide Baseline Analysis Population Description
[Not Specified]
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
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
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%
0
   0.0%
1.Primary Outcome
Title The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Hide Description

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.

Time Frame at 1, 6 and 24 hours after thyroidectomy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Preketorolac Postketorolac Dexamethasone
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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

Overall Number of Participants Analyzed 45 47 45 43
Measure Type: Count of Participants
Unit of Measure: Participants
Sore throat Rest at 1h
43
  95.6%
44
  93.6%
42
  93.3%
41
  95.3%
Sore throat Rest at 6h
32
  71.1%
34
  72.3%
33
  73.3%
25
  58.1%
Sore throat Rest at 24h
20
  44.4%
21
  44.7%
25
  55.6%
15
  34.9%
Sore throat Swallowing at 1h
44
  97.8%
45
  95.7%
44
  97.8%
42
  97.7%
Sore throat Swallowing at 6h
44
  97.8%
42
  89.4%
40
  88.9%
35
  81.4%
Sore throat Swallowing at 24h
42
  93.3%
37
  78.7%
37
  82.2%
29
  67.4%
2.Secondary Outcome
Title The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Hide Description

The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0–3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice)

● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign

Time Frame at 1, 6 and 24 hours after thyroidectomy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Preketorolac Postketorolac Dexamethasone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 45 47 45 43
Measure Type: Count of Participants
Unit of Measure: Participants
Hoarseness at 1h
42
  93.3%
44
  93.6%
40
  88.9%
40
  93.0%
Hoarseness at 6h
37
  82.2%
36
  76.6%
39
  86.7%
35
  81.4%
Hoarseness at 24h
34
  75.6%
28
  59.6%
29
  64.4%
22
  51.2%
3.Other Pre-specified Outcome
Title Potential Side Effects Associated With the Study Drugs
Hide Description Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.
Time Frame at 1, 6 and 24 hours after extubation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Preketorolac Postketorolac Dexamethasone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 45 47 45 43
Measure Type: Count of Participants
Unit of Measure: Participants
Analgesic use at 1h
14
  31.1%
4
   8.5%
6
  13.3%
9
  20.9%
Analgesic use at 6h
2
   4.4%
0
   0.0%
0
   0.0%
0
   0.0%
Analgesic use at 24h
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea at 1h
10
  22.2%
11
  23.4%
13
  28.9%
15
  34.9%
Nausea at 6h
2
   4.4%
7
  14.9%
6
  13.3%
1
   2.3%
Nausea at 24h
0
   0.0%
1
   2.1%
2
   4.4%
0
   0.0%
Vomiting at 1h
0
   0.0%
2
   4.3%
1
   2.2%
1
   2.3%
Vomiting at 6h
0
   0.0%
2
   4.3%
1
   2.2%
0
   0.0%
Vomiting at 24h
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 1h, 6h and 24h after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Preketorolac Postketorolac Dexamethasone
Hide Arm/Group Description

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

All-Cause Mortality
Placebo Preketorolac Postketorolac Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (0.00%)   0/45 (0.00%)   0/43 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Preketorolac Postketorolac Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (0.00%)   0/45 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Preketorolac Postketorolac Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (0.00%)   0/45 (0.00%)   0/43 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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
Responsible Party: Sung Mee Jung, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT02039427     History of Changes
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