Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

Pain Clinical Trial

Official title:

Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00793052
• Other study ID #: TASMC-08-BS-062-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: October 29, 2008
• Last updated: November 16, 2008
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are refered for third molar extraction to our center

• Must be able to swallow tablets

Exclusion Criteria:

• Diabetes mellitus

• Thyroid diseases

• Cardiovascular diseases

• renal diseases

• hepatic diseases

• respiratory system diseases

• adrenal diseases

• Allergy to Etodalac, Etoricoxib or Dexamethasone

• Gastric ulcers

• psychiatric diseases

• Pregnant or breast feeding womans

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Pain
• Trismus

Intervention

Drug:
• Etodalac, Etoricoxib and Dexamethasone
Dexamethasone sodium phosphate 8 mg 1 hour before the extraction, 4 mg the day after the extraction and another 4 mg at second day to the extraction. Etoricoxib 120 mg 1 hour before the extraction, 120 mg the day after the extraction and another 120 mg at second day to the extraction. Etodalac 600 mg 1 hour before the extraction, 600 mg the day after the extraction and another 600 mg at second day to the extraction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAIN- By VAS graded from 1-10 TRISMUS- By MAX mouth opening from the first incisors adages POST OPERATIVE SWELLing - By measurement the distance between the Right and LEFT ear's tragus		1 week	No