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Post Operative Sore Throat and Dexamethasone

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01052038
Enrollment
120
Registered
2010-01-20
Start date
2010-01-31
Completion date
2010-09-30
Last updated
2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Sore Throat

Keywords

Sore throat, Dexamethasone, Pain

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.

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.

Interventions

DRUGPlacebo administration

Placebo administration

DRUGDexamethasone 0.05mg/kr administration

Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.

Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Subjects Assessment of Sore Throat Pain at 24 Hours24 hoursThe 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

MeasureTime frameDescription
Quality of Recovery at 24 Hours24 hoursThe 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
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.
Opioid Consumption at 24 Hours24 hoursThe 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.
Hoarseness at 24 Hours24 hoursSelf 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.

Countries

United States

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 details

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

Participants by arm

ArmCount
Group 1 Placebo
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
40
Group 2: Dexamethasone 0.05mg/kg
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
40
Group 3:Dexamethasone 0.1mg/kg
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
40
Total120

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up231
Overall StudyProtocol Violation233

Baseline characteristics

CharacteristicGroup 2: Dexamethasone 0.05mg/kgGroup 3:Dexamethasone 0.1mg/kgGroup 1 PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants40 Participants40 Participants120 Participants
Age Continuous36 years
STANDARD_DEVIATION 7
39 years
STANDARD_DEVIATION 11
36 years
STANDARD_DEVIATION 11
37 years
STANDARD_DEVIATION 9
Region of Enrollment
United States
40 participants40 participants40 participants120 participants
Sex: Female, Male
Female
40 Participants40 Participants40 Participants120 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
25 / 4019 / 4018 / 40
serious
Total, serious adverse events
0 / 400 / 400 / 40

Outcome results

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.

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
Group 1 PlaceboSubjects Assessment of Sore Throat Pain at 24 Hours4 units on a scale (1 to 5)
Group 2: Dexamethasone 0.05mg/kgSubjects Assessment of Sore Throat Pain at 24 Hours4 units on a scale (1 to 5)
Group 3:Dexamethasone 0.1mg/kgSubjects Assessment of Sore Throat Pain at 24 Hours5 units on a scale (1 to 5)
p-value: <0.001Kruskal-Wallis
p-value: <0.00195% CI: [0, 2]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [0, 2]Wilcoxon (Mann-Whitney)
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.

Time frame: 24 hours

ArmMeasureGroupValue (NUMBER)
Group 1 PlaceboHoarseness at 24 HoursHoarseness at interview noted by patient15 participants
Group 1 PlaceboHoarseness at 24 HoursNo hoarseness5 participants
Group 1 PlaceboHoarseness at 24 HoursHoarseness easily noted by interviewer6 participants
Group 1 PlaceboHoarseness at 24 HoursNo hoarseness at interview but present during 24h10 participants
Group 2: Dexamethasone 0.05mg/kgHoarseness at 24 HoursHoarseness at interview noted by patient11 participants
Group 2: Dexamethasone 0.05mg/kgHoarseness at 24 HoursNo hoarseness at interview but present during 24h6 participants
Group 2: Dexamethasone 0.05mg/kgHoarseness at 24 HoursNo hoarseness11 participants
Group 2: Dexamethasone 0.05mg/kgHoarseness at 24 HoursHoarseness easily noted by interviewer6 participants
Group 3:Dexamethasone 0.1mg/kgHoarseness at 24 HoursNo hoarseness at interview but present during 24h8 participants
Group 3:Dexamethasone 0.1mg/kgHoarseness at 24 HoursNo hoarseness18 participants
Group 3:Dexamethasone 0.1mg/kgHoarseness at 24 HoursHoarseness easily noted by interviewer4 participants
Group 3:Dexamethasone 0.1mg/kgHoarseness at 24 HoursHoarseness at interview noted by patient6 participants
p-value: 0.04Chi-squared, Corrected
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.

Time frame: 3 hours.

ArmMeasureValue (NUMBER)
Group 1 PlaceboNumber of Subjects With Sore Throat at 3 Hours Post Surgery.24 participants
Group 2: Dexamethasone 0.05mg/kgNumber of Subjects With Sore Throat at 3 Hours Post Surgery.17 participants
Group 3:Dexamethasone 0.1mg/kgNumber of Subjects With Sore Throat at 3 Hours Post Surgery.10 participants
p-value: 0.004Chi-squared, Corrected
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.

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
Group 1 PlaceboOpioid Consumption at 24 Hours20 mg of oral morphine equivalents
Group 2: Dexamethasone 0.05mg/kgOpioid Consumption at 24 Hours20 mg of oral morphine equivalents
Group 3:Dexamethasone 0.1mg/kgOpioid Consumption at 24 Hours10 mg of oral morphine equivalents
p-value: 0.01Kruskal-Wallis
p-value: 0.00395% CI: [0, 20]Wilcoxon (Mann-Whitney)
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

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
Group 1 PlaceboQuality of Recovery at 24 Hours171 units on a scale (30 to 200) higher scod
Group 2: Dexamethasone 0.05mg/kgQuality of Recovery at 24 Hours179 units on a scale (30 to 200) higher scod
Group 3:Dexamethasone 0.1mg/kgQuality of Recovery at 24 Hours193 units on a scale (30 to 200) higher scod
p-value: <0.001Kruskal-Wallis
p-value: 0.00595% CI: [14, 29]Wilcoxon (Mann-Whitney)
p-value: 0.00495% CI: [7, 22]Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026