Morphine or Ketamine for Analgesia
MoKA
Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain
3 other identifiers
interventional
1,010
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2024
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
Study Completion
Last participant's last visit for all outcomes
October 31, 2029
January 26, 2026
January 1, 2026
3 years
December 16, 2024
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pain intensity
Self-reported pain intensity measured using the Verbal Numerical Rating Scale (VNRS). Scored from 0 to 10. A higher score indicates a worse outcome.
Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Adverse events, acute
Examples of adverse events include, but are not limited to, cardiopulmonary adverse events (e.g., hypoxia, respiratory depression, hypotension); opioid-related adverse events; and adverse events as measured using the Side Effects Rating Scale of Dissociative Anesthetics (SERSDA).
Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Pain-related function
Pain intensity and related functional limitations due to pain, measured using the Parents' Postoperative Pain Measure (PPPM). Scored from 0 to 10. A higher score indicates a worse outcome.
Days 1, 2,3, 7 and 30 after discharge.
Traumatic stress, primary assessment
Stress related to the pain experienced measured using the Child Stress Disorder Checklist (CSDC-SF). Scored from 0 to 8. A higher score indicates a worse outcome.
Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.
Secondary Outcomes (9)
Receipt of rescue analgesia
Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Desire for same analgesic
At 240 minutes after completion of study drug administration or when a terminal event occurs
Depth of sedation
Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Analgesic/opioid use after discharge
Days 1, 2, 3, 7, 30, 90, and 180 after discharge
Missed school or work
Day 7, 30, 90, 180 after discharge
- +4 more secondary outcomes
Other Outcomes (11)
Global satisfaction
Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Opioid use/misuse
Days 30, 90, and 180 after discharge
Pain catastrophizing
Baseline (at time of enrollment) and day 7 after discharge.
- +8 more other outcomes
Study Arms (2)
Sub-dissociative ketamine
EXPERIMENTAL0.25 mg/kg, maximum dose 25 mg
Morphine
ACTIVE COMPARATOR0.1 mg/kg, maximum dose 8 mg
Interventions
Eligibility Criteria
You may qualify if:
- Abdominal pain or isolated long-bone extremity fracture (suspected or proven)
- Self-reported pain score of ≥ 6/10
- Requires IV morphine for analgesia as determined by the treating physician
You may not qualify if:
- Weight \> 82.4 kg
- Known allergy/contraindication to morphine or ketamine
- Antecedent receipt of ketamine related to presenting complaint
- Inability to use self-report measures of pain or questionnaires
- Chronic disease associated with pain
- Chronic pain condition requiring use of opioids as outpatient
- Hemodynamic instability or critical illness per treating physician
- Altered mental state (e.g., GCS , 14 or clinical intoxication)
- Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta
- Concern for open fracture, neurovascular compromise, or compartment syndrome
- Injuries in addition to the extremity injury (e.g., head, neck, abdomen)
- Known or reported pregnancy
- Does not speak English or Spanish
- Patient previously enrolled in this study
- Wards of state, foster children, or children in custody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UC Davis Children's Hospital
Sacramento, California, 95817, United States
Nemours Children's Hospital
Wilmington, Delaware, 19803, United States
Arthur M. Blank Hospital
Atlanta, Georgia, 30329, United States
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S Tsze, MD, MPH
Columbia University
- PRINCIPAL INVESTIGATOR
Amy L Drendel, DO, MS
Medical College of Wisconsin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics in Emergency Medicine
Study Record Dates
First Submitted
December 16, 2024
First Posted
February 19, 2025
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
October 31, 2029
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The de-identified data will be made available at the conclusion of the project period (currently August 2029, but may be subject to an extension), and any manuscripts published before the end of the project period will have accompanying release of relevant deidentified data at the time of the manuscript publications. The investigators recognize that the NIH may require a particular repository to be used, but otherwise, the investigators intend to submit the end-of-study data to NICHD DASH, in which case the end date of access would be subject to NICHD DASH policies.
- Access Criteria
- Because it is a condition of the NIH for newly funded studies to make data publicly available, the investigators are not sure what the future use may be. For our intended repository (NICHD DASH), applicants to receive the releasable data are required to abide by the User Agreement. The investigators note that if there are published manuscripts before the project period ends, minimal de-identified data would be made available to support the manuscript's reproducibility and enable further work. Such pre-trial-completion releases of deidentified data are to comply with Helping to End Addiction Long-term (HEAL) policies on data availability. The end-of-study deidentified data will be findable and available through the NICHD DASH repository's search functionality. The investigators will also note where the data are available in the primary study manuscript; as required for HEAL Initiative®-funded trials, the publications from this trial will be available as open access.
Consistent with the HEAL Public Access and Data Sharing Policy, one of our goals is to assure rapid data sharing. The de-identified Underlying Primary Data will only be shared when confirmed to be de-identified by the EMSC Data Center (EDC), according to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects, to ensure that the identities of research participants cannot be readily ascertained from the data. Underlying Primary Data will also be stripped of identifiers according to the HIPAA Privacy Rule. The EDC is familiar with these processes given their vast experience with data management. The de-identified data will be made available at the conclusion of the project period, and any manuscripts published before the end of the project period will have accompanying release of relevant deidentified data at the time of the manuscript publications.