Post Operative Sore Throat and Dexamethasone

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01052038
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery.

Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics. The preoperative administration of dexamethasone can decrease the incidence and severity of postoperative sore throat which is rated by patients as one of the most undesirable outcomes in the postoperative period.

Condition or Disease	Intervention/Treatment	Phase
Sore Throat; Pain	Drug: Placebo administration; Drug: Dexamethasone 0.05mg/kr administration; Drug: Dexamethasone 0.1mg/kg	Phase 4

Detailed Description

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction. The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery. It has been observed that gargle with azunol reduced the incidence of postoperative sore throat from 65% to 25 %. Similarly, a reduction in sore throat following tracheal intubation from 78% to 40 % has been reported after gargle with ketamine performed 5 minutes before induction of anesthesia. More recently, it was also demonstrated that preoperative gargle with licorice resulted in a 57 percent reduction of the absolute risk of sore throat after intubation. Although the gargling technique has been shown to be successful in decreasing the incidence of postoperative sore throat, it has a limited feasibility because the volumes administered could increase the chance of aspiration if ingested and it may be difficult to perform in sedated patients and in children.

Tracheal intubation is associated with an increase of polymorphonuclear cells in the tracheal tissue and plasma levels of interleukin 6, suggesting an inflammatory response to the presence of the endotracheal tube itself or to some aspect of the intubation process. Dexamethasone is widely prescribed for the treatment of a sore throat resulting from tracheal mechanical irritation due to its modulating effects of tissue edema and pain. Moreover, prophylactic dexamethasone has been shown to be effective in reducing the frequency of airway obstruction in patients at high risk for laryngeal edema following extubation. It decreases postoperative sore throat in patients requiring double-lumen tubes.

Dexamethasone has been shown to decrease postoperative sore throat in patients requiring hospital admission but it has not been evaluated in the ambulatory setting. Ambulatory patients usually need to return to work faster than patients who are admitted to the hospital. Their ability to tolerate fluids and food might help them to return to normal living. They also have smaller surgeries which might increased their perception to sore throat pain when compared to bigger, more painful procedures.

Possible side effects of corticosteroids such as retardation of wound healing, susceptibility to infection and gastrointestinal hemorrhage have not been noted with short term use (<24 hours ) in surgical patients. Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Systemic Prophylactic Dexamethasone on the Incidence of Postoperative Sore Throat in Patients Undergoing Ambulatory Laparoscopic Gynecologic Surgery: A Prospective, Randomized, Double Blinded, Placebo Controlled Trial
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1 Placebo Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Drug: Placebo administration; Placebo administration; Other Names: Decadron Corticosteroid
Active Comparator: Group 2: Dexamethasone 0.05mg/kg Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Drug: Dexamethasone 0.05mg/kr administration; Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.; Other Names: Decadron corticosteroid
Active Comparator: Group 3:Dexamethasone 0.1mg/kg Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.	Drug: Dexamethasone 0.1mg/kg; Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.; Other Names: Decadron corticosteroid

Outcome Measures

Primary Outcome Measures

1. Subjects Assessment of Sore Throat Pain at 24 Hours [24 hours]

   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.

Secondary Outcome Measures

1. Quality of Recovery at 24 Hours [24 hours]

   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

2. Number of Subjects With Sore Throat at 3 Hours Post Surgery. [3 hours.]

   Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.

3. Opioid Consumption at 24 Hours [24 hours]

   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.

4. Hoarseness at 24 Hours [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients undergoing outpatient laparoscopic gynecologic surgery

• ASA PS I and II

• Age between 18 and 64 years

• Fluent in English

Exclusion Criteria:

• History of recent respiratory tract infection

• Pregnancy, breastfeeding

• Current treatment with analgesics

• Current use of corticosteroids

• Anticipated difficult intubation

• Risk factors for post-operative aspiration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwesten University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Gildasio DeOliveira, M.D., Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01052038
• Other Study ID Numbers: STU00018901
• First Posted: Jan 20, 2010
• Last Update Posted: May 2, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University: Sore throat; Dexamethasone; Pain
• Additional relevant MeSH terms: Pharyngitis; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Recruitment Details	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 Detail	No subjects were lost or excluded after consent was signed and prior to allocation.

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Period Title: Overall Study
STARTED	40	40	40
COMPLETED	36	34	36
NOT COMPLETED	4	6	4

Baseline Characteristics

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg	Total
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.	Total of all reporting groups
Overall Participants	40	40	40	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	40 100%	40 100%	40 100%	120 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (11)	36 (7)	39 (11)	37 (9)
Sex: Female, Male (Count of Participants)
Female	40 100%	40 100%	40 100%	120 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	40 100%	40 100%	40 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Subjects Assessment of Sore Throat Pain at 24 Hours
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [units on a scale (1 to 5)]	4	4	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; 0 to 2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; 0 to 2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Quality of Recovery at 24 Hours
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [units on a scale (30 to 200) higher scod]	171	179	193

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Kruskal-Wallis
	Comments	Dunn's post hoc-test corrected for 12 comparisons.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	22
	Confidence Interval	(2-Sided) 95%; 14 to 29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	14
	Confidence Interval	(2-Sided) 95%; 7 to 22
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Description	Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
Time Frame	3 hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Measure Participants	40	40	40
Number [participants]	24 60%	17 42.5%	10 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Chi-squared, Corrected
	Comments

4. Secondary Outcome

Title	Opioid Consumption at 24 Hours
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [mg of oral morphine equivalents]	20	20	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Kruskal-Wallis
	Comments	Post hoc test using Dunn's test corrected for 12 comparisons

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	10
	Confidence Interval	() 95%; 0 to 20
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Hoarseness at 24 Hours
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Placebo	Group 2: Dexamethasone 0.05mg/kg	Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.	Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery	Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Measure Participants	40	40	40
No hoarseness	5 12.5%	11 27.5%	18 45%
No hoarseness at interview but present during 24h	10 25%	6 15%	8 20%
Hoarseness at interview noted by patient	15 37.5%	11 27.5%	6 15%
Hoarseness easily noted by interviewer	6 15%	6 15%	4 10%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Placebo, Group 2: Dexamethasone 0.05mg/kg, Group 3:Dexamethasone 0.1mg/kg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Time Frame	Adverse events were collected for 24 hours following surgery
Arm/Group Title	Group 1 Placebo		Group 2: Dexamethasone 0.05mg/kg		Group 3:Dexamethasone 0.1mg/kg
Arm/Group Description	Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.		Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery		Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
All Cause Mortality
	Group 1 Placebo		Group 2: Dexamethasone 0.05mg/kg		Group 3:Dexamethasone 0.1mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1 Placebo		Group 2: Dexamethasone 0.05mg/kg		Group 3:Dexamethasone 0.1mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Group 1 Placebo		Group 2: Dexamethasone 0.05mg/kg		Group 3:Dexamethasone 0.1mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/40 (62.5%)		19/40 (47.5%)		18/40 (45%)
Respiratory, thoracic and mediastinal disorders
Hoarseness	20/40 (50%)	20	3/40 (7.5%)	3	6/40 (15%)	6
Coughing	10/40 (25%)	10	8/40 (20%)	8	6/40 (15%)	6
Surgical and medical procedures
Sore throat	25/40 (62.5%)	25	19/40 (47.5%)	19	18/40 (45%)	18

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE 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.