A Phase 3 interventional study of Ketamine hydrochloride and Morphine sulphate in Abdominal Pain, Isolated Extremity Fracture and Pain, sponsored by Columbia University. Recruiting at 8 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Columbia University · Phase 3, Interventional, and Treatment
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.
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.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's planned enrollment of 1,010 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 14, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.25 mg/kg
Drug: Ketamine hydrochloride
0.1 mg/kg
Drug: Morphine sulphate
Sub-dissociative ketamine, IV
Morphine, IV
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.
Desire of rescue analgesia
Number of participants who indicated that they desired a rescue analgesic
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Day 7, 30, 90, 180 after discharge
Anxiety
PROMIS Anxiety 8a. Scored from 8 to 40. A higher score indicates a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at time of enrollment) and day 30 after discharge
Global satisfaction
Global satisfaction with analgesia measured using the Patient Global Impression of Change (PGIC) score. Scored from 1 to 7. A higher score indicates a worse outcome.
Time frame: Up to 240 minutes after completion of study drug administration or until a terminal event occurs
Opioid use/misuse
Name, dose and duration of opioids used to calculate total days of use during the elapsed time since last assessment and indication for use
Time frame: Days 30, 90, and 180 after discharge
Pain catastrophizing
Assessment of heightened negative cognitive and affective pain responses in children. Measured using the Pain Catastrophizing Scale (PCS) for Children. Scored from 0 to 4. A higher score indicates more catastrophizing.
Time frame: Baseline (at time of enrollment) and day 30 after discharge.
Pain interference
How much pain interferes with daily activities measured using the 9-item Child Activity Limitations Interview (CALI-9). Scored from 0 to 100. A higher score indicates a worse outcome.
Time frame: Day 7 after discharge
Physical functioning
Health related quality of life measured using the Pediatric Quality of Life (PedsQL) inventory. Scored from 0 to 100. A higher score indicates a better health-related quality of life.
Time frame: Baseline (at time of enrollment) and day 7 after discharge
Sleep
Impact of pain on sleep measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance 8a + sleep duration. Scored from 8 to 40. A higher score indicates a worse outcome.
Time frame: Baseline (at time of enrollment) and day 7 after discharge
Parent/Guardian/Caregiver Pain Catastrophizing
Pain Catastrophizing Scale (PCS) for Parents. Scored from 0 to 52. A higher score indicates a worse outcome.
Time frame: Day 90 after discharge
Parent/Guardian/Caregiver Pain Depression
Patient Health Questionnaire-2 (PHQ-2). Scored from 0 to 6. If the score is 3 or greater, major depressive disorder is likely.
Time frame: Day 90 after discharge.
Parent/Guardian/Caregiver Pain Anxiety
Generalized Anxiety Disorder 2-item (GAD-2). Scored from 0 to 6. A higher score indicates a worse outcome.
Time frame: Day 90 after discharge
Parent/Guardian/Caregiver Pain Quality of Life
World Health Organization Quality of Life-2 item (WHOQOL-2). Scored from 2 to 10. A higher score indicates a better outcome.
Time frame: Day 90 after discharge
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Data sharing details ↗ · dash.nichd.nih.gov
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ketamine