Sore Throat Prevention Following Intubation

Sore Throat Clinical Trial

Official title:

Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682134
• Other study ID #: AAlJabari
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2016
• Last updated: February 10, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.

Description:

Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).

The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA 1-3.

• Elective VS Emergency.

• Cuffed endo-tracheal tubes.

• Different types of surgery.

Exclusion Criteria:

• Pregnant ladies.

• ICU patients.

• <15 years of age

• Laryngeal mask airway

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

Intervention

Drug:
• xylocaine
First group were given xylocaine
• Dexamethasone
Second group were given Dexamethasone
• Xylocaine and Dexamethasone
Third group were given both Xylocaine and Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.	Questionnaire follow up in intubated patients.	4 months	Yes
Secondary	Sore throat SCALE	Sore throat scale from None,mild,moderate till severe.	4 months	Yes