CTRI/2023/06/053432
Not yet recruiting
Phase 4
Comparison of effect of Transdermal Buprenorphine Patch Vs Non-OpioidAnalgesia on Postoperative outcomes in Oral Sub mucous Fibrosis Patients: â??A Randomized Control Trialâ??
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Sponsor
- AIIMS Jodhpur
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients in the age group between 18\- 65 years
- •2\.Patient with mouth opening \<25mm with unilateral or bilateral fibrotic bands
- •3\.Good physical and mental condition (ASA I and II )
- •4\.Absence of infection or trauma prior to the surgery.
Exclusion Criteria
- •1\.Age \<18 years and \>65 years.
- •2\.Patients/with life\-threatening cardio\-respiratory co\-morbidities with increasing risk of complication during GA like previous MI/under treatment for CAD, COPD patients, severe hepatic and renal impairment, patients with head injury (a condition that increased amount of pressure in the 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 hypersensitivity to buprenorphine
- •7\.Patients who are taking anti\-depressants, and central nervous system depressants.
- •8\.Patients who are taking other opioid drugs, and muscle relaxants like dantrolene, and baclofen.
- •9\.Patients who are taking anti\-retroviral, antifungal drugs.
- •10\.Patients with a coagulation disorder.
Outcomes
Primary Outcomes
Not specified
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