Ketamine for Endometriosis Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a small dose of ketamine, an anesthetic, can reduce pain after surgery for women with endometriosis, a condition causing chronic pelvic pain. Participants will receive either the ketamine treatment or a placebo, a harmless substance resembling the treatment, to compare results. Women with moderate to severe pelvic pain for over six months who plan to undergo robotic surgery to remove endometriosis may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications like lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are not allowed. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that ketamine has been safely used for various medical purposes, often as an anesthetic and for pain management. Studies have found that low doses, like the one tested in this trial, are usually well-tolerated. The FDA has already approved ketamine for other uses, supporting its safety.
Some people might experience side effects with ketamine, such as dizziness, nausea, or a sensation of floating. However, serious side effects are rare, especially at low doses. In past research, patients reported that ketamine helps relieve pain without causing many problems.
Overall, existing evidence suggests that ketamine at low doses is safe for most people. However, discussing its potential effects with a doctor is important to understand personal implications.12345Why do researchers think this study treatment might be promising for endometriosis pain?
Unlike the standard treatments for endometriosis, which often include hormonal therapies and pain relievers, ketamine offers a novel approach. Ketamine is unique because it acts as an NMDA receptor antagonist, which can help block pain signals in the nervous system. Researchers are excited about ketamine because it could potentially provide fast-acting pain relief, offering an alternative for those who have not found success with existing options. Additionally, ketamine's effect on chronic pain conditions might pave the way for a new understanding of managing endometriosis pain.
What evidence suggests that ketamine might be an effective treatment for endometriosis pain?
Studies have shown that ketamine can relieve pain in various conditions. For example, one study examined past cases and found that esketamine, a type of ketamine, helped 64.7% of patients with long-term pain from endometriosis. Other research suggests that ketamine can relieve pain, with 30–40% of patients experiencing good results. Additionally, a review of multiple studies found that ketamine provided significant pain relief lasting up to two weeks after treatment. In this trial, participants in the Low-Dose Ketamine (LDK) Treatment Group will receive ketamine to evaluate its effectiveness in reducing post-surgery pain in endometriosis patients.56789
Who Is on the Research Team?
Kathy Huang, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adult women aged 18-65 with chronic pelvic pain who are scheduled for robotic endometriosis removal surgery. Participants should be medically stable and willing to follow the study procedures throughout its duration.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subanesthetic dose of ketamine or placebo postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain, anxiety, depression, and opioid use
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
- Placebo
Ketamine is already approved in United States, European Union, Canada for the following indications:
- Anesthesia
- Treatment-resistant depression
- Anesthesia
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor