Abdominal PainPhase 3MoKANCT06835504
Morphine or Ketamine for Analgesia
A Phase 3 study testing Ketamine hydrochloride and Morphine sulphate in people with Abdominal Pain and Isolated Extremity Fracture, run by Columbia University at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Abdominal Pain, Isolated Extremity Fracture, Pain
- What is being tested?
- Ketamine hydrochloride and Morphine sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Oct 2026to 23 Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to < 18 years old
- Chief complaint includes 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
Who cannot join
- Weighs more than 81.9 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 conditions requiring use of opioids as an outpatient
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- Abnormal vital signs at baseline, defined as oxygen saturation <92% and/or low respiratory rate and/or low heart rate and/or low blood pressure per age
- 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
- Patients who are breastfeeding
- Patient or parent/guardian does not speak English or Spanish
- Patient previously enrolled in this study
- Known significant or uncontrolled cardiovascular disease
- Known increased intracranial pressure and/or elevated intraocular pressure
- Currently taking or having used a monoamine oxidase inhibitor within 14 days
- Wards of state, foster children, or children in custody
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amy L Drendel, DO, MS contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Arthur M. Blank Hospital
Atlanta, Georgia, 30329
Becky Burger, MD, 404-785-5437, beckyburger@emory.edu
Claudia R Morris, claudia.r.morris@emory.edu
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Deborah Liu, MD, 323-660-2450, deliu@chla.usc.edu
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Amy L Drendel, DO, MS, 877-266-8989, adrendel@mcw.edu
- Not yet recruiting
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
Daniel S Tsze, MD, MPH, 212-305-6628, dst2141@cumc.columbia.edu
Raquel Shrager, rs3823@cumc.columbia.edu
- Not yet recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Maren Lunoe, MD, 412-692-5325, maren.lunoe@chp.edu
Bob Hickey, MD, robert.hickey@chp.edu
- Recruiting
UC Davis Children's Hospital
Sacramento, California, 95817
Leah Tzimenatos, MD, 800-282-3284, lstzimenatos@ucdavis.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Eileen Klein, MD, MPH, 206-987-8811, eileen.klein@seattlechildrens.org
- Recruiting
Nemours Children's Hospital
Wilmington, Delaware, 19803
Amy Thompson, MD, MSCR, 302-651-4200, amy.thompson@nemours.org
About this study
Official title: Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain
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.
Read the detailed description
Aim 1: To determine if IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children presenting to an ED with acute pain. The investigators hypothesize that IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children with acute abdominal pain or an extremity fracture.
Aim 2: To compare the rate of acute (<2 hours) adverse events, including cardiopulmonary adverse events requiring an intervention, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events requiring an intervention 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
- Abdominal Pain, Isolated Extremity Fracture, Pain, Pediatrics
- Being tested
- Ketamine hydrochloride, Morphine sulphate
- Keywords
- Ketamine, Morphine, Pediatric, Children, Sub-dissociative, Opioid-sparing, Emergency medicine, Emergency care, Emergency department, Post-traumatic stress, Anxiety, Depression, Abdominal pain, Fracture, Analgesia
- Medical subject headings
- Abdominal Pain, Pain, Emergencies, Anxiety Disorders, Depression, Fractures, Bone, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine hydrochlorideDrug
Sub-dissociative ketamine, IV
Morphine sulphateDrug
Morphine, IV
| Study group | Role | What they receive |
|---|---|---|
| Sub-dissociative ketamine | Experimental | 0.25 mg/kg Receives: Drug: Ketamine hydrochloride |
| Morphine | Active comparator | 0.1 mg/kg Receives: Drug: Morphine sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 240 minutes after completion of study drug administration or until a terminal event occurs
Cardiopulmonary adverse events requiring an intervention
Cardiopulmonary adverse events (e.g., hypoxia, respiratory depression, hypotension) requiring an intervention (e.g., isotonic fluid bolus; vasopressor; chest compression; naloxone; supplemental oxygen; non-invasive positive pressure ventilation; bag-valve-mask ventilation; tracheal intubation)
Measured: 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.
Measured: Days 1, 2,3, and 7 after discharge.
Post-traumatic stress
Stress related to the pain experienced measured using the University of California Los Angeles Post-Traumatic Stress Disorder (UCLA PTSD). Scored from 0 to 80. A higher score indicates a worse outcome.
Measured: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.
Secondary outcomes (10)
Desire of rescue analgesia
Number of participants who indicated that they desired a rescue analgesic
Measured: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Desire for same analgesic
Number of participants who would want the same analgesic (i.e., study medication) again in the future.
Measured: At 240 minutes after completion of study drug administration or when a terminal event occurs
Depth of sedation
Depth of sedation measured using the University of Michigan Sedation Scale (UMSS). Scored from 0 to 4. 0 is deepest level of sedation (unarousable), 4 is awake and alert.
Measured: Up to 240 minutes after completion of study drug administration or until a terminal event occurs
Adverse events, non-cardiopulmonary
Adverse events that are non-cardiopulmonary and can include (but are not limited to) opioid-related adverse events or those as measured using the Side Effects Rating Scale of Dissociative Anesthetics (SERSDA).
Measured: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Analgesic/opioid use after discharge
Name, dose and duration of analgesics and/or opioids used to calculate total days of use during the elapsed time since last assessment
Measured: Days 1, 2, 3, 7, 30, 90, and 180 after discharge
Missed school or work
Days of missed school or work related to the chief complaint.
Measured: Day 7 after discharge
Return visit
Number of return visits related to the chief complaint, which can include (but not limited to) return visits to the emergency department or primary care physician
Measured: Day 7, 30, 90, 180 after discharge
Anxiety
PROMIS Anxiety 8a. Scored from 8 to 40. A higher score indicates a worse outcome.
Measured: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge
Depression
Patient-Reported Outcomes Measurement Information System (PROMIS). Scored from 8 to 40. A higher score indicates a worse outcome.
Measured: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge
Substance use
National Institute on Drug Abuse (NIDA) modified assist tool. Scored from 0 to 360. A higher score indicates a worse outcome.
Measured: Baseline (at time of enrollment) and day 30 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start17 Oct 2026
- Primary completion23 Apr 2030 (estimated)
- Study completion23 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority trial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia UniversityAmy L Drendel, DO, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835504
- Sponsor's protocol ID
- AAAV7115
- Other IDs
- U01HD116253, IRB00181652
- Acronym
- MoKA
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.