Pain control in post-operative OSMF patients.

Not Applicable

Completed

• Conditions: Health Condition 1: K135- Oral submucous fibrosisHealth Condition 2: K135- Oral submucous fibrosis

• Registration Number: CTRI/2018/10/016007
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-13
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1.Patient with mouth opening <25mmwith unilateral or bilateral fibrotic bands

2.Good physical and mental condition (ASA I ,II )

3.Absence of infection or trauma prior to the surgery.

Exclusion Criteria

1.Age <16 years and >65 years.

2.Patients/with life threatening cardio-respiratory co-morbidities increasing risk of complication during GA likeprevious MI/under treatment for CAD,COPD patients, severe hepatic and renal impairment, patients with head injury (condition that increased amount of pressure in brain),opioid tolerant patients.

3.A history of allergy to the drugs used in the present study.

4.All pregnant and lactating females.

5.Alcohol or narcotics abusers.

6.Patients with ulcerative lesions or malignant lesions.

7.Patients with hypersensitivity to fentanyl.

8.Patients who are taking MAO inhibitors.

9.Patients who are taking drugs for migraines.

10.Patients who are taking anti-retroviral, antifungal drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain: Assessing Pain using Visual analogue scale (VAS) <br/ ><br>2. Mouth Opening (Passive+Active) will be measured postoperatively with vernier calliper/scale <br/ ><br>Timepoint: 1,3,5,7,9,15 day 1,3 months

Secondary Outcome Measures

Name	Time	Method
1. Quality of life <br/ ><br>2. Patient co operationTimepoint: 1,3,5,7,9,15 day 1,3 months