18 Participants Needed

Ketorolac for Blood Vessel Function

(VDR Trial)

Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Milton S. Hershey Medical Center
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Ketorolac is generally considered safe for humans, but there are some risks. It has been associated with bleeding in certain surgeries and eye complications when used in high doses. Always consult with a healthcare provider for personalized advice.45678

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

I understand the study and can agree to participate.
Any race or ethnicity
Fluent in written and spoken English
See 4 more

Exclusion Criteria

Subjects with ferromagnetic metal implants
Subjects who are claustrophobic
I am either younger than 21 or older than 35.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo wrist-to-elbow occlusion procedure with ketorolac tromethamine and saline infusions to study the venous distension reflex

3-4 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ketorolac Tromethamine
  • Saline Control
  • Wrist-to-elbow (W-E) Occlusion
Trial OverviewThe study tests how ketorolac tromethamine (a painkiller) affects the body's response to vein stretching in the arm. It compares this drug's effect with a saline solution using MRI scans to observe changes in vein size during the process.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetorolacExperimental Treatment2 Interventions
The Wrist-to-Elbow occlusion procedure will be performed followed by 2 ketorolac tromethamine + saline infusions into the occluded arm.
Group II: ControlPlacebo Group2 Interventions
The Wrist-to-Elbow occlusion procedure will be performed followed by 2 saline only infusions into the occluded arm.

Ketorolac Tromethamine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Toradol for:
  • Moderate to severe pain
  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Menstrual disorders
  • Headaches
🇪🇺
Approved in European Union as Ketorolac for:
  • Moderate to severe pain
  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Menstrual disorders
  • Headaches
🇨🇦
Approved in Canada as Ketorolac for:
  • 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

Trials
515
Recruited
2,873,000+

Findings from Research

A single dose of ketorolac significantly prolonged bleeding times and reduced platelet aggregation in a rat model, indicating its strong anti-thrombotic effects immediately after administration.
Despite its initial effectiveness in preventing thrombosis, ketorolac was ineffective for long-term prevention of microarterial thrombosis, and its use may pose a risk of bleeding complications in postoperative patients.
Effects of ketorolac tromethamine (Toradol) on a functional model of microvascular thrombosis.Buckley, RC., Davidson, SF., Das, SK.[2019]
In a study of 100 male patients undergoing laparoscopic inguinal hernia repair, the combination of ketorolac tromethamine and dezocine significantly reduced fluctuations in heart rate and mean arterial pressure during recovery compared to control, indicating better hemodynamic stability.
Patients receiving the combination treatment also reported lower pain scores and higher sedation levels post-surgery, suggesting enhanced analgesic and sedative effects without increasing the risk of adverse reactions.
Effect of ketorolac tromethamine combined with dezocine prior administration on hemodynamics and postoperative analgesia in patients undergoing laparoscopic hernia repair.Wu, Y., Cai, Z., Li, Y., et al.[2023]
In a randomized study involving patients after extensive colonic resections, the combination of intramuscular ketorolac and patient-controlled intravenous morphine provided equal pain relief compared to morphine alone, without increasing side effects.
The use of ketorolac significantly reduced the need for narcotics by an average of 45%, making it a valuable option for patients at risk of narcotic-related complications.
Ketorolac and patient controlled analgesia in the treatment of postoperative pain.Cataldo, PA., Senagore, AJ., Kilbride, MJ.[2013]

References

Effects of ketorolac tromethamine (Toradol) on a functional model of microvascular thrombosis. [2019]
Effect of ketorolac tromethamine combined with dezocine prior administration on hemodynamics and postoperative analgesia in patients undergoing laparoscopic hernia repair. [2023]
Ketorolac and patient controlled analgesia in the treatment of postoperative pain. [2013]
Toradol following Breast Surgery: Is There an Increased Risk of Hematoma? [2021]
Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. [2022]
Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. [2019]
Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. [2019]
Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac: a case-control study within a cohort (2001-2010). [2022]
Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Bioavailability of two sublingual formulations of ketorolac tromethamine 30 mg: a randomized, open-label, single-dose, two-period crossover comparison in healthy Mexican adult volunteers. [2014]
Plasma prostaglandin E2 concentrations after single dose administration of ketorolac tromethamine (Toradol) in dogs. [2018]