Morphine or Ketamine for Pain

(MoKA Trial)

Recruiting at 7 trial locations

Overseen By Amy L Drendel, DO, MS

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Columbia University

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: 0

1010 Participants Needed

Trial Summary

What is the purpose of this trial?

Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.

Research Team

Amy L Drendel, DO, MS

Principal Investigator

Medical College of Wisconsin

Daniel S Tsze, MD, MPH

Principal Investigator

Columbia University

Eligibility Criteria

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)

Treatment Details

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.

Participant Groups

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+