Procedural Pain Clinical Trial
Official title:
The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial
NCT number | NCT06310850 |
Other study ID # | KEAH-238 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 1, 2013 |
Est. completion date | June 1, 2023 |
Verified date | March 2024 |
Source | Ankara Ataturk Sanatorium Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who underwent elective thoracic surgery via thoracotomy - Patients with ASA physical status I-III Exclusion Criteria: - Describing chronic pain, - Have a bleeding disorder, - Having a history of analgesia drug use, - Have a history of liver disease, - Have serious metabolic and endocrine problems, - Have a history of allergy to ketamine and local anesthetics, - Have an infection in the intervention area, - Rejecting thoracic epidural catheter, - Describing acute pain in any part of the body during the preoperative evaluation, - Thoracic epidural catheter duration greater than five minutes (time from needle entry to catheter placement) - Patients requiring more than two Tuohy injection attempts |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Atatürk Sanatorium Training and Research Hospital | Ankara | Keçiören |
Lead Sponsor | Collaborator |
---|---|
Ankara Ataturk Sanatorium Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog scale (VAS) | For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P). | 1 day (5 times) |
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