Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use Disorder
Phase 4
- Conditions
- Health Condition 1: F112- Opioid dependence
- Registration Number
- CTRI/2021/09/036462
- Lead Sponsor
- GMC RH Patiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Male and female patients aged 18-65 years with ICD-10 diagnosis of Opioid Dependence.
2.Patients who will bw mdeically stable.
3.Patients who have given written informed consent.
Exclusion Criteria
1. History of chronic psychosis or drug induced psychosis of any kind.
2. Patients with paralytic ileus and respiratory depression.
3. Pregnant women, lactating mothers, surgically-sterile women or women who agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test.
4. History of seizures, renal insufficiency or congestive heart failure.
5. History of ketamine abuse/dependence or prior clinically significant adverse reaction to ketamine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome will be improvement on the BPI (Brief Pain Inventory scale)Timepoint: Patients will be assessed at baseline ,2hrs,3hrs, 6hrs, 24hrs, 48hrs, 72hrs.
- Secondary Outcome Measures
Name Time Method ADRTimepoint: After every session