Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy
This research is investigating pain control during a common kidney stone treatment called Extracorporeal Shockwave Lithotripsy (ESWL). ESWL uses shockwaves to break up kidney and urinary tract stones, which can be painful. The study aims to find out if a pain relief plan that doesn't use strong opioid medications is as effective as, or more effective than, the current standard approach which includes opioids. Participants will receive one of two pain medication combinations during their ESWL procedure. Doctors will then check their pain levels and how well they tolerate the treatment, as well as any side effects. The goal is to see if we can find good pain relief without always needing opioids.
At a glance
What is this study about?
When you have kidney stones, one common treatment is called Extracorporeal Shockwave Lithotripsy, or ESWL. This treatment uses special shockwaves from outside your body to break the stones into tiny pieces so they can pass more easily. While it's a very helpful procedure, these shockwaves can cause discomfort or pain, so patients are usually given medication to help them feel comfortable during the treatment.
Currently, many places use pain relief medicines that include opioids (strong painkillers) because they work well. However, doctors are increasingly looking for ways to manage pain effectively without relying too much on opioids, especially because of concerns about opioid addiction. This study wants to see if a different combination of medicines, which doesn't include opioids, can provide similar or even better pain relief during ESWL.
Basically, the research is comparing two different pain relief options given through a drip (IV) during your kidney stone treatment. One option uses a mild calming medicine (midazolam) along with two non-opioid pain relievers (acetaminophen and ketorolac). The other option, which is the current standard, uses the mild calming medicine (midazolam) with an opioid pain reliever (fentanyl). By comparing these, the study hopes to find the best way to keep patients comfortable during ESWL while also reducing the need for opioids where possible.
Key takeaways
- This study compares two pain relief methods for kidney stone treatment (ESWL).
- One method uses non-opioid painkillers, the other uses traditional opioid painkillers.
- The goal is to find effective pain relief with fewer opioids.
- Participants will be randomly assigned to one of the two pain relief groups.
- Pain levels and side effects will be carefully monitored.
- You won't know which pain relief you receive to keep the results fair.
Who may be eligible?
To take part in this study, you need to be at least 19 years old and scheduled to have the ESWL treatment for kidney stones. You also need to be able to fully understand the study details and agree to take part.
There are some reasons why you might not be able to join. For example, if you've had ESWL in the last six months, or if you've taken strong pain medicines (narcotics) in the two days before the study. You also can't participate if you're allergic to any of the medicines used in the study, like midazolam, fentanyl, acetaminophen, or ketorolac.
Certain health conditions would also exclude you, such as serious kidney or liver problems, an active stomach ulcer, or if you're taking blood thinners. Pregnant individuals are also not able to join the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 19 years old or older?
- Are you scheduled for an ESWL procedure for kidney stones?
- Have you avoided strong painkillers (narcotics) in the last 48 hours?
- Are you NOT pregnant?
- Do you NOT have serious kidney or liver disease?
- Are you NOT allergic to midazolam, fentanyl, acetaminophen, or ketorolac?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to receive one of two pain medication combinations through a drip (intravenous, or IV) during your ESWL procedure. This means you won't choose which combination you get, and neither will the doctors giving it to you. You also won't know which combination you've received, to make sure the results are fair.
Before your ESWL treatment begins, and again about 30 minutes after it finishes, you will be asked to rate your pain on a simple scale. During your treatment, the study team will also keep an eye on how well you tolerate the procedure, for example, how many shockwaves are delivered successfully. They will also monitor for any side effects from the medication, such as low blood pressure, issues with your oxygen levels, or feeling sick.
Overall, your participation in the study would involve your ESWL treatment as planned, with specific pain relief given, and a couple of brief pain assessments before and after the procedure.
Potential risks and benefits
Locations (1)
- St. Joseph's HospitalVerified postcodeSaint John, Canada
Common questions
What is ESWL?
ESWL stands for Extracorporeal Shockwave Lithotripsy. It's a treatment that uses sound waves from outside your body to break up kidney stones into smaller bits so they can pass more easily.
Why is this study important?
This study is important because it's looking for ways to effectively manage pain during ESWL without always needing strong opioid painkillers, which can have unwanted side effects.
Will I know which pain medication I'm getting?
No, you won't know which pain medication combination you receive. This helps make sure the study results are fair and unbiased.
What kind of pain scale will I use?
You'll be asked to rate your pain on a simple scale, usually from 0 (no pain) to 10 (worst pain imaginable), both before and after your treatment.
Can I stop being part of the study at any time?
Yes, you can decide to stop participating in the study at any point, and it won't affect the medical care you receive for your kidney stones.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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