Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1010 participants
INTERVENTIONAL
2026-05-01
2029-10-31
Brief Summary
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Detailed Description
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Aim 2: To compare the rate of acute (\<2 hours) adverse events, including cardiopulmonary adverse events, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events associated with IV sub-dissociative ketamine compared to IV morphine.
Aim 3: To determine the relationship between ketamine and long-term sequelae of acute pain. The investigators hypothesize that children who receive ketamine will have better levels of pain-related function during the first week following ED presentation and will have greater odds of experiencing more favorable post-traumatic stress, anxiety and depression outcomes 1-6 months after ED presentation compared to children who received IV morphine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sub-dissociative ketamine
0.25 mg/kg, maximum dose 25 mg
Ketamine hydrochloride
Sub-dissociative ketamine, IV
Morphine
0.1 mg/kg, maximum dose 8 mg
Morphine sulphate
Morphine, IV
Interventions
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Ketamine hydrochloride
Sub-dissociative ketamine, IV
Morphine sulphate
Morphine, IV
Eligibility Criteria
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Inclusion Criteria
2. Self-reported pain score of ≥ 6/10
3. Requires IV morphine for analgesia as determined by the treating physician
Exclusion Criteria
2. Known allergy/contraindication to morphine or ketamine
3. Antecedent receipt of ketamine related to presenting complaint
4. Inability to use self-report measures of pain or questionnaires
5. Chronic disease associated with pain
6. Chronic pain condition requiring use of opioids as outpatient
7. Hemodynamic instability or critical illness per treating physician
8. Altered mental state (e.g., GCS , 14 or clinical intoxication)
9. Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta
10. Concern for open fracture, neurovascular compromise, or compartment syndrome
11. Injuries in addition to the extremity injury (e.g., head, neck, abdomen)
12. Known or reported pregnancy
13. Does not speak English or Spanish
14. Patient previously enrolled in this study
15. Wards of state, foster children, or children in custody
6 Years
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Daniel S Tsze, MD, MPH
Professor of Pediatrics in Emergency Medicine
Principal Investigators
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Daniel S Tsze, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Amy L Drendel, DO, MS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
Nemours Children's Hospital
Wilmington, Delaware, United States
Arthur M. Blank Hospital
Atlanta, Georgia, United States
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00181652
Identifier Type: OTHER
Identifier Source: secondary_id
AAAV7115
Identifier Type: -
Identifier Source: org_study_id
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