Post Operative Sore Throat and Dexamethasone

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052038
• Other study ID #: STU00018901
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: April 5, 2012
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: April 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain
• Pharyngitis
• Sore Throat

Intervention

Drug:
• Placebo administration
Placebo administration
• Dexamethasone 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
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.

Locations

Country	Name	City	State
United States	Northwesten University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours	No
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	24 hours	No
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.	3 hours.	No
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.	24 hours	No
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.	24 hours	No