Ketorolac for Blood Vessel Function
(VDR Trial)
Trial Summary
What is the purpose of this trial?
The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that affect your cardiovascular or nervous system to participate in this trial.
What data supports the effectiveness of the drug Ketorolac Tromethamine for blood vessel function?
Ketorolac Tromethamine is known for its strong pain-relieving effects and ability to reduce the need for narcotics after surgery, as shown in studies where it decreased narcotic requirements by up to 45%. It also has anti-inflammatory properties and can inhibit platelet aggregation, which might be relevant for blood vessel function.12345
Is ketorolac generally safe for humans?
How does the drug ketorolac tromethamine differ from other treatments for blood vessel function?
Ketorolac tromethamine is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that not only helps with pain relief but also strongly inhibits platelet aggregation, which can affect blood clotting. This dual action may influence blood vessel function differently compared to other treatments that do not have these combined effects.1491011
Eligibility Criteria
This trial is for healthy adults aged 21-35, fluent in English, weighing over 50 kg, and without chronic medical conditions. Participants must not have taken NSAIDs recently or be allergic to them. Pregnant women, individuals with high blood pressure or metal implants, and those on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo wrist-to-elbow occlusion procedure with ketorolac tromethamine and saline infusions to study the venous distension reflex
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketorolac Tromethamine
- Saline Control
- Wrist-to-elbow (W-E) Occlusion
Ketorolac Tromethamine is already approved in United States, European Union, Canada for the following indications:
- Moderate to severe pain
- Rheumatoid arthritis
- Osteoarthritis
- Ankylosing spondylitis
- Menstrual disorders
- Headaches
- Moderate to severe pain
- Rheumatoid arthritis
- Osteoarthritis
- Ankylosing spondylitis
- Menstrual disorders
- Headaches
- Moderate to severe pain
- Rheumatoid arthritis
- Osteoarthritis
- Ankylosing spondylitis
- Menstrual disorders
- Headaches
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor