Pain Clinical Trial
Official title:
Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups: 1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline 2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL) The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - English Speaking patients who are age 18 or older - Patient must be able to provide own consent and communicate with staff - Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC) Exclusion Criteria - Intubated or sedated patients - Agitated patients requiring moderate sedation prior to TRA - Patient's undergoing femoral access for the LHC - Non-English speaking patients - Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure <65), Bradycardia (heart rate<40) - Emergent cardiac catheterization - Inability to obtain radial artery access - Conversion to radial artery access from another access site |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radial Artery Spasm | The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access. | approximately 30 minutes | |
Primary | Pain Prior to Intra-arterial Calcium Channel Blocker Administration | Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10). | 30 seconds prior to administration | |
Primary | Pain After Intra-arterial Calcium Channel Blocker Administration | Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10). | 30 seconds post administration |
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