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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06835504). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1010 participants (ESTIMATED). Conditions: Abdominal Pain, Isolated Extremity Fracture, Pain, Pediatrics. Interventions: DRUG: Ketamine hydrochloride; DRUG: Morphine sulphate. Primary outcome measures: Pain intensity , Up to 240 minutes after completion of study drug administration or until a terminal event occurs; Cardiopulmonary adverse events requiring an intervention , Up to 120 minutes after completion of study drug administration or until a terminal event occurs; Pain-related function , Days 1, 2,3, and 7 after discharge.; Post-traumatic stress , Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.. 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.