Trial Outcomes & Findings for The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery (NCT NCT02039427)
NCT ID: NCT02039427
Last Updated: 2017-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
192 participants
Primary outcome timeframe
at 1, 6 and 24 hours after thyroidectomy
Results posted on
2017-08-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
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
|
Preketorolac
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
|
Postketorolac
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
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 Study
STARTED
|
48
|
48
|
48
|
48
|
|
Overall Study
COMPLETED
|
45
|
47
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo
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
|
Preketorolac
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
|
Postketorolac
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
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 Study
Duration of surgery > 3h
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal on concent
|
0
|
0
|
0
|
1
|
|
Overall Study
Cancellation of surgery
|
0
|
0
|
1
|
0
|
|
Overall Study
Loss of follow - up
|
1
|
0
|
2
|
4
|
|
Overall Study
Steroid Use
|
1
|
0
|
0
|
0
|
Baseline Characteristics
The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml
|
Preketorolac
n=47 Participants
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
|
Postketorolac
n=45 Participants
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
n=43 Participants
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
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
180 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
47.8 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
180 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at 1, 6 and 24 hours after thyroidectomyThe 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.
Outcome measures
| Measure |
Placebo
n=45 Participants
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml
|
Preketorolac
n=47 Participants
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
|
Postketorolac
n=45 Participants
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
n=43 Participants
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
|
|---|---|---|---|---|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Swallowing at 6h
|
44 Participants
|
42 Participants
|
40 Participants
|
35 Participants
|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Swallowing at 24h
|
42 Participants
|
37 Participants
|
37 Participants
|
29 Participants
|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Rest at 6h
|
32 Participants
|
34 Participants
|
33 Participants
|
25 Participants
|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Rest at 24h
|
20 Participants
|
21 Participants
|
25 Participants
|
15 Participants
|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Rest at 1h
|
43 Participants
|
44 Participants
|
42 Participants
|
41 Participants
|
|
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Sore throat Swallowing at 1h
|
44 Participants
|
45 Participants
|
44 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: at 1, 6 and 24 hours after thyroidectomyThe 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
Outcome measures
| Measure |
Placebo
n=45 Participants
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml
|
Preketorolac
n=47 Participants
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
|
Postketorolac
n=45 Participants
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
n=43 Participants
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
|
|---|---|---|---|---|
|
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Hoarseness at 1h
|
42 Participants
|
44 Participants
|
40 Participants
|
40 Participants
|
|
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Hoarseness at 6h
|
37 Participants
|
36 Participants
|
39 Participants
|
35 Participants
|
|
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
Hoarseness at 24h
|
34 Participants
|
28 Participants
|
29 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 1, 6 and 24 hours after extubationPotential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.
Outcome measures
| Measure |
Placebo
n=45 Participants
Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml
|
Preketorolac
n=47 Participants
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
|
Postketorolac
n=45 Participants
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
n=43 Participants
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
|
|---|---|---|---|---|
|
Potential Side Effects Associated With the Study Drugs
Vomiting at 6h
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Analgesic use at 1h
|
14 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Analgesic use at 6h
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Analgesic use at 24h
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Nausea at 1h
|
10 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Nausea at 6h
|
2 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Nausea at 24h
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Vomiting at 1h
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Potential Side Effects Associated With the Study Drugs
Vomiting at 24h
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Postketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sung Mee Jung, M.D
Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea
Phone: +82-53-620-3368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place