Post Operative Sore Throat and Dexamethasone - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Sore Throat Pain
Interventions:	Drug: Placebo administration Drug: Dexamethasone 0.05mg/kr administration Drug: Dexamethasone 0.1mg/kg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
ASA physical status I and II females undergoing outpatient gynaecological laparoscopy. Patients with a history of recent respiratory tract infection (<1 month), current use of an opioid analgesic or corticosteroid, pregnancy, or anticipated difficult airways were not enrolled. Subjects were enrolled between January 2010 thru September 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No subjects were lost or excluded after consent was signed and prior to allocation.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Participant Flow: Overall Study

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
STARTED	40	40	40
COMPLETED	36	34	36
NOT COMPLETED	4	6	4
Lost to Follow-up	2	3	1
Protocol Violation	2	3	3

Baseline Characteristics

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Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Total	Total of all reporting groups

Baseline Measures

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg	Total
Number of Participants [units: participants]	40	40	40	120
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	40	40	40	120
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	36 ± 11	36 ± 7	39 ± 11	37 ± 9
Gender [units: participants]
Female	40	40	40	120
Male	0	0	0	0
Region of Enrollment [units: participants]
United States	40	40	40	120

Outcome Measures

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1. Primary:

Subjects Assessment of Sore Throat Pain at 24 Hours [ Time Frame: 24 hours ]

Measure Type	Primary
Measure Title	Subjects Assessment of Sore Throat Pain at 24 Hours
Measure Description	The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.
Time Frame	24 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Measured Values

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Number of Participants Analyzed [units: participants]	40	40	40
Subjects Assessment of Sore Throat Pain at 24 Hours [units: units on a scale (1 to 5)] Median ( Inter-Quartile Range )	4 ( 3 to 5 )	4 ( 3 to 5 )	5 ( 4 to 5 )

Statistical Analysis 1 for Subjects Assessment of Sore Throat Pain at 24 Hours

Groups ^[1]	All groups
Method ^[2]	Kruskal-Wallis
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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Statistical Analysis 2 for Subjects Assessment of Sore Throat Pain at 24 Hours

Groups ^[1]	Group 1 Placebo vs. Group 3:Dexamethasone 0.1mg/kg
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	<0.001
Median Difference (Net) ^[4]	1
95% Confidence Interval	( 0 to 2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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Statistical Analysis 3 for Subjects Assessment of Sore Throat Pain at 24 Hours

Groups ^[1]	Group 2: Dexamethasone 0.05mg/kg vs. Group 3:Dexamethasone 0.1mg/kg
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	<0.001
Median Difference (Net) ^[4]	1
95% Confidence Interval	( 0 to 2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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2. Secondary:

Quality of Recovery at 24 Hours [ Time Frame: 24 hours ]

Measure Type	Secondary
Measure Title	Quality of Recovery at 24 Hours
Measure Description	The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery
Time Frame	24 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Measured Values

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Number of Participants Analyzed [units: participants]	40	40	40
Quality of Recovery at 24 Hours [units: units on a scale (30 to 200) higher scod] Median ( Inter-Quartile Range )	171 ( 160 to 182 )	179 ( 175 to 185 )	193 ( 192 to 195 )

Statistical Analysis 1 for Quality of Recovery at 24 Hours

Groups ^[1]	All groups
Method ^[2]	Kruskal-Wallis
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Dunn's post hoc-test corrected for 12 comparisons.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Quality of Recovery at 24 Hours

Groups ^[1]	Group 1 Placebo vs. Group 3:Dexamethasone 0.1mg/kg
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.005
Median Difference (Net) ^[4]	22
95% Confidence Interval	( 14 to 29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Quality of Recovery at 24 Hours

Groups ^[1]	Group 2: Dexamethasone 0.05mg/kg vs. Group 3:Dexamethasone 0.1mg/kg
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.004
Median Difference (Net) ^[4]	14
95% Confidence Interval	( 7 to 22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Number of Subjects With Sore Throat at 3 Hours Post Surgery. [ Time Frame: 3 hours. ]

Measure Type	Secondary
Measure Title	Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Measure Description	Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
Time Frame	3 hours.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Measured Values

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Number of Participants Analyzed [units: participants]	40	40	40
Number of Subjects With Sore Throat at 3 Hours Post Surgery. [units: participants]	24	17	10

Statistical Analysis 1 for Number of Subjects With Sore Throat at 3 Hours Post Surgery.

Groups ^[1]	All groups
Method ^[2]	Chi-squared, Corrected
P Value ^[3]	0.004

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

4. Secondary:

Opioid Consumption at 24 Hours [ Time Frame: 24 hours ]

Measure Type	Secondary
Measure Title	Opioid Consumption at 24 Hours
Measure Description	The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.
Time Frame	24 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Measured Values

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Number of Participants Analyzed [units: participants]	40	40	40
Opioid Consumption at 24 Hours [units: mg of oral morphine equivalents] Median ( Inter-Quartile Range )	20 ( 20 to 30 )	20 ( 10 to 32.5 )	10 ( 10 to 20 )

Statistical Analysis 1 for Opioid Consumption at 24 Hours

Groups ^[1]	All groups
Method ^[2]	Kruskal-Wallis
P Value ^[3]	0.01

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Post hoc test using Dunn's test corrected for 12 comparisons
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Opioid Consumption at 24 Hours

Groups ^[1]	Group 1 Placebo vs. Group 3:Dexamethasone 0.1mg/kg
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.003
Median Difference (Net) ^[4]	10
95% Confidence Interval	( 0 to 20 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

5. Secondary:

Hoarseness at 24 Hours [ Time Frame: 24 hours ]

Measure Type	Secondary
Measure Title	Hoarseness at 24 Hours
Measure Description	Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.
Time Frame	24 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1 Placebo	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Measured Values

	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Number of Participants Analyzed [units: participants]	40	40	40
Hoarseness at 24 Hours [units: participants]
No hoarseness	5	11	18
No hoarseness at interview but present during 24h	10	6	8
Hoarseness at interview noted by patient	15	11	6
Hoarseness easily noted by interviewer	6	6	4

Statistical Analysis 1 for Hoarseness at 24 Hours

Groups ^[1]	All groups
Method ^[2]	Chi-squared, Corrected
P Value ^[3]	0.04

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was limited to 2 doses of dexamethasone and was underpowered to assess side effects such as hyperglycemia or delayed wound healing. Study was limited to a single type of surgery and results may differ in different types of surgery.

Results Point of Contact:

Name/Title: Dr. Robert J. McCarthy
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu

Publications of Results:

De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.

Responsible Party:	Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:	NCT01052038 History of Changes
Other Study ID Numbers:	STU00018901
Study First Received:	January 19, 2010
Results First Received:	October 31, 2011
Last Updated:	April 5, 2012
Health Authority:	United States: Institutional Review Board