1010 Participants Needed

Morphine or Ketamine for Pain

(MoKA Trial)

Recruiting at 7 trial locations
DS
AL
Overseen ByAmy L Drendel, DO, MS
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Columbia University
Must be taking: Morphine
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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 the combination of morphine and ketamine safe for pain management?

Studies show that combining ketamine with morphine for pain management can lead to more adverse effects like vivid dreaming and cognitive issues, but no severe adverse events were reported. Ketamine alone may cause more side effects than morphine, but it is generally considered safe in humans.12345

How does the drug combination of ketamine and morphine differ from other pain treatments?

The combination of ketamine and morphine for pain relief is unique because ketamine can enhance the pain-relieving effects of morphine while potentially reducing its side effects like nausea and vomiting. Ketamine works differently by blocking specific receptors in the brain, which may provide more effective pain relief compared to using higher doses of morphine alone.16789

What data supports the effectiveness of the drugs ketamine and morphine for pain relief?

Research shows that ketamine can be an effective alternative or addition to morphine for pain relief in some cases, such as in emergency settings for acute pain. However, when combined with morphine for post-surgery pain, ketamine did not show additional benefits and even caused some side effects like vivid dreaming.48101112

Who Is on the Research Team?

DS

Daniel S Tsze, MD, MPH

Principal Investigator

Columbia University

AL

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)
See 11 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Sub-dissociative ketamineExperimental Treatment1 Intervention
0.25 mg/kg, maximum dose 25 mg
Group II: MorphineActive Control1 Intervention
0.1 mg/kg, maximum dose 8 mg

Find a Clinic Near You

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

Adding ketamine to morphine for patient-controlled analgesia after major abdominal surgery: a double-blinded, randomized controlled trial. [2019]
Clinical benefits related to the combination of ketamine with morphine for patient controlled analgesia after major abdominal surgery. [2013]
BET 2: Low-dose ketamine for acute pain in the ED. [2017]
Ketamine as adjuvant to opioids for cancer pain. A qualitative systematic review. [2019]
Efficacy and Safety of Morphine and Low Dose Ketamine for Pain Control of Patients with Long Bone Fractures: A Randomized, Double-Blind, Clinical Trial. [2022]
Morphine with adjuvant ketamine versus higher dose of morphine alone for acute pain: a meta-analysis. [2020]
Intravenous analgesia for out-of-hospital traumatic pain in adults: ketamine gives a greater reduction in pain than morphine but causes more adverse effects. [2013]
A systematic review and meta-analysis comparing the efficacy and safety of ketamine versus morphine for the treatment of acute pain. [2023]
Safety of mixture of morphine with ketamine for postoperative patient-controlled analgesia: an audit with 1026 patients. [2015]
Non-inferiority of intranasal ketamine compared to intravenous morphine for musculoskeletal pain relief among older adults in an emergency department: a randomised controlled trial. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Intrathecal ketamine reduces morphine requirements in patients with terminal cancer pain. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
The use of ketamine as rescue analgesia in the recovery room following morphine administration--a double-blind randomised controlled trial in postoperative patients. [2018]
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