Clinical trial

The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial

Name
KEAH-238
Description
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.
Trial arms
Trial start
2013-06-01
Estimated PCD
2023-01-01
Trial end
2023-06-01
Status
Completed
Phase
Early phase I
Treatment
Ketamine
Patients will be administered 0.15 mg kg-1 intravenous ketamine (The sample provided contains equal proportions of two enantiomers, S and R ketamine hydrochloride.) 3 minutes before thoracic epidural catheter placement.
Arms:
Group Ketamine
Placebo
Intravenous saline will be administered to patients 3 minutes before the thoracic epidural catheter is placed.
Arms:
Group Placebo
Size
60
Primary endpoint
Visual analog scale (VAS)
1 day (5 times)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed as a randomized, prospective study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-03-15

1 organization

1 drug

3 indications

Indication
Thoracic
Indication
Procedural Pain