Ketamine for Acute Pain

Overseen By Christy Wise, B.A.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Summa Health System

Must not be taking: Opiates, Alcohol, Others

Disqualifiers: Pregnant, Unstable heart disease, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the impact of ketamine, administered through an IV, on individuals experiencing severe pain in the Emergency Department. The main goal is to determine if administering ketamine over 30 minutes, instead of 15 minutes, reduces side effects while still effectively controlling pain. Participants will receive ketamine over either 15 or 30 minutes to compare the outcomes. Suitable candidates for this trial are individuals 18 or older, able to give consent, and experiencing significant pain from conditions such as musculoskeletal or chest pain. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you have not used fentanyl within 60 minutes or other opiates within 4 hours before joining. Chronic use of opiates is also not allowed. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What is the safety track record for ketamine?

Research has shown that ketamine is a safe and effective treatment for sudden, severe pain when used in small amounts. Studies have found that doses under 0.5 mg/kg usually do not cause major side effects. In cases of sudden pain, ketamine can lower pain levels and reduce the need for stronger painkillers like opioids. While ketamine may cause less nausea and vomiting than opioids, some people report feeling more restless. Overall, ketamine is well-tolerated in the doses used for sudden pain relief, making it a promising option for managing severe pain in emergency situations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike typical pain treatments like opioids, which can be addictive and have numerous side effects, ketamine offers a unique approach for managing acute pain. Researchers are excited about ketamine because it acts on the NMDA receptors in the brain, providing rapid pain relief without the same risk of addiction that opioids carry. Additionally, this trial is exploring different durations of ketamine administration—15 minutes versus 30 minutes—which could help optimize pain management strategies. This has the potential to offer a faster, safer alternative for pain relief that could be particularly beneficial in emergency settings.

What is the effectiveness track record for ketamine in treating acute pain?

Studies have shown that ketamine effectively treats both short-term and long-term pain. Research indicates that small doses of ketamine can manage pain in various situations, such as after surgery and during cancer treatment. One study found that low doses of ketamine, which do not cause mind-altering effects, significantly reduce pain flare-ups in people with chronic pain. Additionally, ketamine often controls pain during surgeries and can reduce the need for other pain medications. This trial will compare two different administration durations of ketamine: one group will receive a 0.25 mg/kg dose over 15 minutes, while another group will receive the same dose over 30 minutes. This treatment has provided good pain relief for many patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Pallaci, DO, FACEP

Principal Investigator

Summa Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the Emergency Department with acute, severe pain from conditions like abdominal or musculoskeletal pain. They must be alert, oriented, and able to consent. Excluded are pregnant or breastfeeding individuals, those with altered mental status or unstable vitals, recent drug/alcohol use, certain psychiatric conditions, recent analgesic use, chronic opiate users, and those with specific heart diseases.

Inclusion Criteria

I experience pain in my abdomen, back, sides, muscles, or chest due to injury.

My pain level is at least a 5 out of 10.

I am fully aware of who I am, where I am, and the current time.

Exclusion Criteria

I regularly use strong painkillers like fentanyl.

I haven't used fentanyl in the last hour or other painkillers in the last 4 hours.

I have a history of serious heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive low dose ketamine infusion for pain management over 15 or 30 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for side effects and pain control using VAS and SERSDA scales

90 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview The study tests if a low dose of Ketamine given slowly through an IV over 30 minutes reduces side effects compared to a faster infusion over 15 minutes while still controlling severe pain effectively in emergency situations.

How Is the Trial Designed?

Group I: Ketamine 30 Minutes Experimental Treatment 1 Intervention

Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.

Group II: Ketamine 15 Minutes Active Control 1 Intervention

Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.

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?

Summa Health System

Lead Sponsor

Trials

31

Recruited

3,200+

Published Research Related to This Trial

In a study involving six healthy volunteers, both intramuscular (i.m.) and oral ketamine at a dose of 0.5 mg/kg effectively increased pain thresholds and prolonged pain-free exercise during a tourniquet test.

The i.m. route required a higher plasma concentration of ketamine (150 ng/ml) for analgesia compared to the oral route (40 ng/ml), suggesting that oral ketamine may be effective due to higher levels of its metabolite norketamine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and analgesic effects of i.m. and oral ketamine. Grant, IS., Nimmo, WS., Clements, JA.[2022]

In a study of 69 gynecological surgery patients, low dose ketamine (0.15 mg/Kg) administered preoperatively did not provide a preemptive analgesic effect, as indicated by similar pain scores at rest compared to placebo.

However, patients receiving ketamine postoperatively experienced less pain upon movement on the fifth day and required less morphine in the first 6 hours, suggesting that while preemptive use is ineffective, postoperative ketamine can still improve pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of low-dose intravenous ketamine in postoperative analgesia for hysterectomy and adnexectomy]. Gilabert Morell, A., Sánchez Pérez, C.[2013]

In a study involving 7 patients with severe pain, epidural administration of 4 mg ketamine resulted in pain relief for all participants, with effects lasting from 30 minutes to over 6 hours.

Ketamine's use in this context showed no adverse side effects or neurological damage, and it presents a safer alternative to opioids, as it is unlikely to cause respiratory depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural ketamine. A preliminary report. Mankowitz, E., Brock-Utne, JG., Cosnett, JE., et al.[2014]

Intramuscular administration of ketamine provides rapid absorption with a high bioavailability of 93%, making it an effective route for achieving analgesic effects in healthy volunteers.

Oral administration of ketamine results in only 17% absorption due to extensive first-pass metabolism, leading to minimal pain relief, highlighting the importance of administration route for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability, pharmacokinetics, and analgesic activity of ketamine in humans. Clements, JA., Nimmo, WS., Grant, IS.[2021]

S(+)-Ketamine, at half the dose of ketamine racemate, provides similar analgesic effects while causing fewer adverse effects on cognitive functions and a smaller increase in heart rate, making it a promising option for emergency medicine.

In a study involving 16 healthy volunteers, S(+)-ketamine resulted in significantly less anterograde amnesia compared to ketamine racemate, suggesting it may be safer for use in situations where maintaining cognitive function is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychometric changes as well as analgesic action and cardiovascular adverse effects of ketamine racemate versus s-(+)-ketamine in subanesthetic doses]. Pfenninger, E., Baier, C., Claus, S., et al.[2013]

Citations

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

Ketamine - StatPearls - NCBI Bookshelf - NIH Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain. Acad Emerg Med. 2019 Sep;26(9):1044-1051 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10447145/

Application of Ketamine in Pain Management and the ... Ketamine is commonly used to treat various kinds of chronic pain syndromes and is also applied to control perioperative pain and reduce the consumption of ...

3. mdpi.com mdpi.com/2227-9032/12/16/1560

The Efficacy of Ketamine for Acute and Chronic Pain in ... The efficacy of ketamine for acute and chronic pain in patients with cancer: a systematic review of randomized controlled trials.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06534-z

ketamine hydrochloride injection for postoperative acute pain ... Besides, it has been reported that less than 50% of patients receive adequate postoperative analgesia, and the proportion of postoperative acute ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395999000445

Use and efficacy of low-dose ketamine in the management ... The evidence suggests that low-dose ketamine may play an important role in postoperative pain management when used as an adjunct to local anesthetics, opioids, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11679605/

The Impact of Ketamine on Outcomes in Acute Pain ... Evidence shows that intravenous ketamine reduces the pain intensity, postoperative opioid use, and the risk of vomiting and nausea while improving analgesia.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S073567572400473X

Low-dose ketamine for acute pain: A narrative review Ketamine doses <0.5 mg/kg were not associated with significant side effects. Conclusions. LDK is a safe and effective option for acute pain treatment. It can be ...

8. medicine.uams.edu medicine.uams.edu/emergencymedicine/wp-content/uploads/sites/13/2024/06/JC-Summary-Feb-2023.pdf

Safety and Efficacy of low dose ketamine (LDK) compared ... When comparing ketamine to opioid medication for the management of acute pain, these studies do not seem to suggest that ketamine is more effective than ...

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06511-6

Ketamine for acute pain after trauma: the KAPT randomized ... There is evidence that ketamine is effective in in bolus form for treating acute pain in the pre-hospital and emergency room setting but data ...

10. bmjopen.bmj.com bmjopen.bmj.com/content/10/11/e038134

Ketamine for the treatment of prehospital acute pain This systematic literature review finds that ketamine probably reduces pain more than opioids and with less nausea and vomiting but higher risk of agitation.