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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Placebo | Placebo Comparator | Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery. |
|
| Group 2: Dexamethasone 0.05mg/kg | Active Comparator | Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery |
|
| Group 3:Dexamethasone 0.1mg/kg | Active Comparator | Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo administration | Drug | Placebo administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Assessment of Sore Throat Pain at 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio DeOliveira, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwesten University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21669954 | Result | 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. |
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No subjects were lost or excluded after consent was signed and prior to allocation.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Placebo | Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery. |
| FG001 | Group 2: Dexamethasone 0.05mg/kg | Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery |
| FG002 | Group 3:Dexamethasone 0.1mg/kg | Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Placebo | Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery. |
| BG001 | Group 2: Dexamethasone 0.05mg/kg | Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects Assessment of Sore Throat Pain at 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. | Posted | Median | Inter-Quartile Range | units on a scale (1 to 5) | 24 hours |
|
Adverse events were collected for 24 hours following surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Placebo | Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Surgical and medical procedures | SNOMED CT | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert J. McCarthy | Northwestern University Feinberg School of Medicine | 312-926-9015 | r-mccarthy@northwestern.edu |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D000305 | Adrenal Cortex Hormones |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexamethasone 0.05mg/kr administration | Drug | Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery. |
|
|
| Dexamethasone 0.1mg/kg | Drug | Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery. |
|
|
| 24 hours |
| Number of Subjects With Sore Throat at 3 Hours Post Surgery. | Subjects were asked at 3 hours post surgery if they were experiencing a sore throat. | 3 hours. |
| Opioid Consumption at 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. | 24 hours |
| Hoarseness at 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. | 24 hours |
| BG002 | Group 3:Dexamethasone 0.1mg/kg | Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Group 3:Dexamethasone 0.1mg/kg |
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery. |
|
|
|
| Secondary | Quality of Recovery at 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 | Posted | Median | Inter-Quartile Range | units on a scale (30 to 200) higher scod | 24 hours |
|
|
|
|
| Secondary | Number of Subjects With Sore Throat at 3 Hours Post Surgery. | Subjects were asked at 3 hours post surgery if they were experiencing a sore throat. | Posted | Number | participants | 3 hours. |
|
|
|
|
| Secondary | Opioid Consumption at 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. | Posted | Median | Inter-Quartile Range | mg of oral morphine equivalents | 24 hours |
|
|
|
|
| Secondary | Hoarseness at 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. | Posted | Number | participants | 24 hours |
|
|
|
|
| 0 |
| 40 |
| 25 |
| 40 |
| EG001 | Group 2: Dexamethasone 0.05mg/kg | Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery | 0 | 40 | 19 | 40 |
| EG002 | Group 3:Dexamethasone 0.1mg/kg | Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery. | 0 | 40 | 18 | 40 |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 0.005 |
| Median Difference (Net) |
| 22 |
| 2-Sided |
| 95 |
| 14 |
| 29 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.004 | Median Difference (Net) | 14 | 2-Sided | 95 | 7 | 22 | No | Superiority or Other |
| 0.003 |
| Median Difference (Net) |
| 10 |
| 95 |
| 0 |
| 20 |
| No |
| Superiority or Other |
|
| Hoarseness at interview noted by patient |
|
| Hoarseness easily noted by interviewer |
|