Post Operative Sore Throat and Dexamethasone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01052038
First received: January 19, 2010
Last updated: April 5, 2012
Last verified: April 2012
Results First Received: October 31, 2011  
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
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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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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.
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:
  No text entered.
[2] Other relevant method 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.

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:
  No text entered.
[2] Other relevant method 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 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 method 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.



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 method 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 method 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 method 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 method 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 method 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 method 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 method 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


  Other Adverse Events


  Limitations and Caveats
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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.


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