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Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use Disorder

To Evaluate The Therapeutic Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use Disorder

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036462
Enrollment
40
Registered
2021-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: Tapentadol: Patients will be give single session of intranasal tapentadol Control Intervention1: Ketamine: Patients will be given single session of subcutaneous ketamine

Sponsors

GMC RH Patiala
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
ADRTimepoint: After every session

Countries

India

Contacts

Public ContactDr Ramanpreet Kaur

Department of Psychiatry

dr.ramanpreet90@gmail.com7087766328

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026