The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery

• 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: Yeungnam University College of Medicine
• 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

Participant Flow

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
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
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

Baseline Characteristics

Arm/Group Title		Placebo	Preketorolac	Postketorolac	Dexamethasone	Total
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	Total of all reporting groups
Overall Number of Baseline Participants		45	47	45	43	180
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%

Outcome Measures

1. Primary Outcome

Title	The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Preketorolac	Postketorolac	Dexamethasone
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
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Preketorolac	Postketorolac	Dexamethasone
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Preketorolac	Postketorolac	Dexamethasone
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%

Adverse Events

Time Frame	1h, 6h and 24h after surgery
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo	Preketorolac	Postketorolac	Dexamethasone
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%)
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%)
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%)

Limitations and Caveats

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.

More Information

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
• 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