Morphine or Ketamine for Pain

(MoKA Trial)

Not yet recruiting at 7 trial locations

Overseen By Amy L Drendel, DO, MS

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Columbia University

Must be taking: Morphine

Disqualifiers: Chronic pain, Schizophrenia, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to manage pain in children visiting the emergency room by comparing two treatments: morphine, the usual choice for strong pain, and ketamine, which might have fewer side effects. The goal is to determine if ketamine can be as effective as morphine for treating severe pain while offering greater safety. Children with significant abdominal pain or a broken bone who need morphine for pain relief might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially safer pain management options for children.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a chronic pain condition requiring opioids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low doses of ketamine are safe for treating sudden pain. Studies have found it effective without leading to more serious side effects. For example, one study found no additional side effects within 30 minutes of using ketamine for pain relief outside of a hospital. Another study noted that while ketamine might cause more short-term and minor side effects than opioids, these are usually not serious.

In contrast, morphine, a common treatment for moderate to severe pain, is well-known but has its own issues. It can cause serious side effects, and both caregivers and doctors express concern about its use because it is an opioid.

Both ketamine and morphine have been extensively studied, but ketamine might have fewer side effects, especially for children. This makes it a potentially safer option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new approaches to managing pain. Unlike the standard of care, which typically involves opioids like morphine, ketamine acts on a different target in the brain. It blocks NMDA receptors, which might help manage pain with potentially fewer side effects. Additionally, sub-dissociative ketamine is used at doses that avoid the hallucinations associated with higher doses, making it a promising alternative for pain relief. This trial could pave the way for more effective, safer pain management options.

What evidence suggests that this trial's treatments could be effective for acute pain in children?

This trial will compare the effectiveness of Morphine and sub-dissociative Ketamine for pain management. Studies have shown that low doses of ketamine, which participants in this trial may receive, can effectively manage acute pain in children, providing significant relief without the heavy sedation often associated with other painkillers. Research indicates that using ketamine at these low doses can reduce the need for additional pain medication, making it a promising alternative to morphine. While morphine effectively treats moderate to severe pain, it has more concerning side effects. Ketamine's lower risk of side effects makes it appealing for long-term use. Both treatments are effective, but the choice may depend on side effects and the patient's specific needs. ^{1 2 5 6 7}

Who Is on the Research Team?

Daniel S Tsze, MD, MPH

Principal Investigator

Columbia University

Amy L Drendel, DO, MS

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for children who come to the emergency department with moderate to severe pain due to conditions like non-specific abdominal pain, other types of abdominal pain, general pain issues, or broken bones. Specific eligibility criteria are not provided.

Inclusion Criteria

My pain level is 6 or higher on a scale of 10.

I need IV morphine for pain as advised by my doctor.

I have abdominal pain or a suspected/proven long-bone fracture.

Exclusion Criteria

Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta

I am allergic to morphine or ketamine.

Altered mental state (e.g., GCS < 14 or clinical intoxication)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either IV sub-dissociative ketamine or IV morphine for acute pain management

Up to 2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain-related function and mental health outcomes

6 months

Multiple assessments at days 1, 2, 3, 7, 30, 90, and 180 after discharge

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Morphine

Trial Overview The study is testing whether ketamine hydrochloride can be as effective as morphine sulphate in managing acute pain in children without the serious side effects often associated with opioids like morphine.

How Is the Trial Designed?

Group I: Sub-dissociative ketamine Experimental Treatment 1 Intervention

0.25 mg/kg, maximum dose 25 mg

Group II: Morphine Active Control 1 Intervention

0.1 mg/kg, maximum dose 8 mg

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6117536/

Sub-dissociative dose ketamine administration for managing ... In addition, our study showed significant decreases in overall post-SDK analgesics administration for patients with abdominal, musculoskeletal, and neuropathic ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675723002760

Efficacy of analgesic and sub-dissociative dose ketamine ... Sub-dissociative dose ketamine (0.1–0.6 mg/kg) is safe and effective for the management of acute pain in the ED. However, the optimal dose of intravenous ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02920528

Subdissociative Dose Ketamine for Treatment of Acute ... The primary endpoint was clinically significant pain relief defined a priori as a decrease in the pain VAS of at least 20 mm from baseline, which was ...

4. acep.org acep.org/siteassets/new-pdfs/preps/sub-dissociative-dose-ketamine-for-analgesia---prep.pdf

Sub-dissociative Dose Ketamine for Analgesia Low-dose ketamine improves pain relief in patients receiving intravenous opioids for pain acute pain in the emergency department; results of a randomized,.

5. journals.lww.com journals.lww.com/ccmjournal/fulltext/2023/01001/811__evaluation_of_subdissociative_dose_ketamine.776.aspx

evaluation of subdissociative-dose ketamine for procedural ... Conclusions: Sub-dissociative dose ketamine administration for PSA in the ED provided comparable procedural sedation and analgesia success at lower doses ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814327

Ketamine Compared With Morphine for Out-of-Hospital ... We did not observe any increase in adverse events after 30 minutes of out-of-hospital pain management among patients with data available (5 of ...

7. acep.org acep.org/painmanagement/newsroom/jan2021/sub-dissociative-dose-ketamine-in-the-emergency-department

Sub-Dissociative Dose Ketamine in the Emergency ... Several trials have demonstrated no differences in pain control compared to opioids, but with relatively higher rates of short-lived and minor ...