Ketamine for Endometriosis Pain

Overseen By Vaishali Shah

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Must not be taking: Lamotrigine, Alfentanil, others

Disqualifiers: Cognitive impairment, Schizophrenia, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

I am scheduled for a robotic surgery to remove endometriosis.

You are in good overall health.

I am willing and able to follow the study rules and attend all appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subanesthetic dose of ketamine or placebo postoperatively

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, anxiety, depression, and opioid use

12 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Placebo

Trial Overview

The UPKEEP Study tests if a low dose of ketamine (0.6 mg/kg) can better manage postoperative pain compared to a saline placebo in female patients after robotic endometriosis surgery. It's randomized and single-blinded, meaning participants won't know which treatment they receive.

How Is the Trial Designed?

Group I: Low-Dose Ketamine (LDK) Treatment Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

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

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1.

physiciansweekly.com

physiciansweekly.com/post/potential-of-esketamine-infusion-therapy-for-chronic-endometriosis-associated-pain

Esketamine Infusion Shows 64.7% Response Rate for ...

Retrospective study shows esketamine infusion therapy achieved 64.7% response rate in 17 patients with chronic endometriosis-associated pain ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4014022/

Ketamine for chronic pain: risks and benefits - PMC

Irrespective of treatment, efficacy is limited with just 30–40 % of patients showing adequate to good pain relief. The remaining population either displays no ...

3.

withpower.com

withpower.com/trial/phase-1-postoperative-pain-3-2022-bdb3f

Ketamine for Endometriosis Pain · Info for Participants

This trial is testing whether a small dose of ketamine can help reduce pain after surgery in women with chronic pelvic pain from endometriosis.

4.

researchgate.net

researchgate.net/publication/333047286_Ketamine_Infusions_for_Chronic_Pain_A_Systematic_Review_and_Meta-analysis_of_Randomized_Controlled_Trials

Ketamine Infusions for Chronic Pain: A Systematic Review ...

Three studies reported significant analgesic benefit favoring ketamine, with the meta-analysis revealing a small effect up to 2 weeks after the ...

5.

jpsmjournal.com

jpsmjournal.com/article/S0885-3924(23)00777-7/fulltext

Efficacy and Safety of Ketamine to Treat Cancer Pain in ...

The results were consistent with ketamine's analgesic effects on postoperative pain. Zhu et al. included six RCTs involving 294 patients ...

6.

dailymed.nlm.nih.gov

dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e8f864-8b8a-4e7e-8439-e510d3107063

Label: KETALAR- ketamine hydrochloride injection - DailyMed

KETALAR use in pregnancy, including obstetrics (either vaginal or abdominal delivery), is not recommended because safe use has not been established [see ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf

KETALAR (ketamine hydrochloride) injection

In surgical procedures involving visceral pain pathways, KETALAR should be supplemented with an agent which obtunds visceral pain. Use with caution in the ...

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK470357/

Ketamine - StatPearls - NCBI Bookshelf - NIH

In addition to its anesthetic applications, ketamine proves invaluable in pain management, addressing treatment-resistant depression, managing ...

9.

go.drugbank.com

go.drugbank.com/drugs/DB01221

Ketamine: Uses, Interactions, Mechanism of Action

Ketamine is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal-laryngeal reflexes.