Ketamine Infusion for Neuralgia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Non-traumatic causes, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

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 ketamine infusions can reduce nerve pain in individuals with specific arm injuries. It focuses on those experiencing neuropathic pain after a traumatic brachial plexus injury, which affects the network of nerves from the spine to the shoulder. Participants will receive either standard care or ketamine infusions, an anesthetic, during and after surgery. Suitable candidates for this trial are those with nerve-related pain from a traumatic brachial plexus injury who require surgical reconstruction. As a Phase 4 trial, this research aims to understand how the FDA-approved and effective ketamine treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketamine infusion?

Research has shown that ketamine is generally safe for treating pain. In several studies, patients who received ketamine experienced significant pain relief, with side effects usually mild and manageable. For example, in a study with 50 patients, side effects like hallucinations were rare and typically not serious.

Other research supports ketamine's safety. A standard infusion method had high completion rates, indicating that most patients could finish their treatment without major problems. No serious adverse events were reported, and patients experienced both physical and mental improvement.

Overall, ketamine appears to be a safe option for managing pain, with minimal side effects, making it a promising choice for individuals dealing with long-term pain conditions. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for neuralgia, which often involve oral medications like anticonvulsants or antidepressants, ketamine infusion offers a new approach by acting directly on the NMDA receptors in the brain. This unique mechanism may help in reducing pain more effectively and quickly compared to traditional options. Researchers are excited about ketamine because it could provide faster relief for patients with chronic pain and has the potential to work for those who haven't responded to other treatments.

What evidence suggests that ketamine infusion might be an effective treatment for neuropathic pain?

Research has shown that ketamine can help reduce long-lasting nerve pain when added to regular treatments. In this trial, participants in the Ketamine Infusion Group will receive ketamine infusion during their planned surgery and postoperatively. One study found that ketamine provided significant pain relief to people with nerve pain. Another study noted that ketamine's pain-reducing effects lasted for several days, but these effects seemed to lessen with ongoing use. Despite this, many patients have completed ketamine infusions, leading to lasting improvements in both physical and mental health. ^{1 4 6 7 8}

Who Is on the Research Team?

Alexander Shin, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with severe nerve pain due to traumatic brachial plexus injuries, confirmed by CT myelogram. Participants must experience specific types of neuropathic pain and score over 4/10 on a specialized pain questionnaire. They should be scheduled for surgery at Mayo Clinic. Excluded are those without pain, under 18, not needing surgery, or with conditions like liver disease or schizophrenia that make ketamine use risky.

Inclusion Criteria

I am scheduled for nerve surgery at Mayo Clinic due to pain from a severe arm injury.

I have nerve pain scoring over 4 on a specific pain questionnaire.

You have nerve damage in your spine as shown on a CT myelogram.

Exclusion Criteria

I do not have severe liver issues, heart disease, or uncontrolled schizophrenia.

I do not have pain after a severe shoulder nerve injury.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ketamine infusion or placebo during surgery and in the 24-hour postoperative period

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with pain measured at various time points up to 6 months post-surgery

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine Infusion

Trial Overview The study tests whether ketamine given during surgery can help reduce the intense nerve pain associated with brachial plexus avulsion injuries. It measures patients' neuropathic pain levels before and after their operations to see if there's any improvement.

How Is the Trial Designed?

Group I: Ketamine Infusion Group Experimental Treatment 1 Intervention

Subjects will receive ketamine infusion during their planned surgery and postoperatively.

Group II: Standard of Care Group Active Control 1 Intervention

Subjects will receive general anesthesia as standard of care during their planned surgery

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

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Depression (off-label)

Approved in European Union as Ketanest for:

• Anesthesia
• Pain management

Approved in Canada as Ketamine for:

• Anesthesia
• Pain management

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A single preoperative dose of S-ketamine (0.5 mg/kg) did not significantly reduce the incidence of chronic postsurgical pain (CPSP) or acute postoperative pain in patients undergoing video-assisted thoracoscopic surgery (VATS).

However, S-ketamine improved sleep quality on the first postoperative day compared to the placebo, while showing no significant differences in anxiety levels or adverse effects between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Preoperative Dose of S-Ketamine Has No Beneficial Effect on Chronic Postsurgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgical Lung Lesion Resection: A Prospective Randomized Controlled Study. Zhou, R., Zhang, Y., Tang, S., et al.[2023]

Ketamine has been found to be an effective treatment for chronic pain conditions, including cancer-related neuropathic pain, and can help reduce the need for opioids by counteracting opioid-induced hyperalgesia.

At sub-anesthetic doses, ketamine demonstrates a significantly improved safety profile and fewer adverse events compared to its use as an anesthetic, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Use for Cancer and Chronic Pain Management. Culp, C., Kim, HK., Abdi, S.[2021]

A patient with cancer-related neuropathic pain, unresponsive to standard treatments, was successfully treated with intrathecal administration of S(+)-ketamine alongside morphine, indicating its potential as an effective pain management option.

The continuous administration of S(+)-ketamine over 3 months resulted in low plasma levels and no significant side effects, suggesting a favorable safety profile for this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term intrathecal S(+)-ketamine in a patient with cancer-related neuropathic pain. Benrath, J., Scharbert, G., Gustorff, B., et al.[2018]

Intranasal ketamine is effective for managing acute pain in children, showing similar pain reduction compared to intranasal fentanyl, based on a meta-analysis of 4 trials involving 276 patients.

While ketamine had a higher risk of non-serious adverse events compared to fentanyl, it did not lead to any serious adverse events, making it a potential alternative to opioids for pediatric pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal ketamine for acute pain management in children: A systematic review and meta-analysis. Oliveira J E Silva, L., Lee, JY., Bellolio, F., et al.[2021]

A meta-analysis of 12 studies involving 88 patients indicates that Ketamine significantly reduces neuropathic pain compared to placebo, although the effects are typically short-lived after administration.

Ketamine has shown promise as an alternative to opioids for chronic pain management, with some studies reporting positive long-term outcomes, but further research with larger sample sizes is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. Wiedemann, B.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9007468/

Efficacy and Safety of Ketamine in the Treatment of ... There is a statistically significant pain reduction by adding ketamine to the treatment of chronic NP when compared to the standard treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8374709/

Efficacy of ketamine in relieving neuropathic pain These results indicate long-term ketamine anti-allodynic effects after chronic exposure (>3 days) but not after a single administration.

3. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2019-0032

How Effective is Ketamine in the Management of Chronic ... 10% of the patients given ketamine exhibited a 50% or greater reduction in pain score after 3 weeks compared with 18% for placebo (Χ2 [3] = 1.1, p = 0.76) [ ...

4. journals.lww.com journals.lww.com/pain/fulltext/2021/09000/efficacy_of_ketamine_in_relieving_neuropathic.3.aspx

Efficacy of ketamine in relieving neuropathic pain The final analysis (6 comparisons) showed that chronic administration caused a slow loss of relief of allodynia with 70% loss of effect 24 days after end of ...

5. rapm.bmj.com rapm.bmj.com/content/early/2025/10/05/rapm-2025-106907

Standardized ketamine infusion protocol for chronic ... We observed high completion rates (86.1% completing 5+ infusions), no serious adverse events, and sustained improvements in physical and mental ...

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

Ketamine for chronic pain: risks and benefits - PMC In clinical practice, ketamine is considered safe, and in general, side effects are well tolerated. We recently treated 50 CRPS-1 patients with a 100 h ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06916403

Safety and Efficacy of Ketamine Intravenous Infusions in ... In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic ...

8. newsroom.clevelandclinic.org newsroom.clevelandclinic.org/2025/10/06/cleveland-clinic-study-demonstrates-safety-effectiveness-of-ketamine-for-chronic-pain

Cleveland Clinic Study Demonstrates Safety, Effectiveness ... The research demonstrated that low-dose ketamine was safe, with minimal side effects. Hallucinations, the most reported side effect, were rare.