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RECRUITING Phase 3 ClinicalTrials.gov

Morphine or Ketamine for Analgesia

Sponsor: Columbia University • ClinicalTrials.gov ID: NCT06835504

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Ketamine hydrochloride (Drug)
    Sub-dissociative ketamine, IV
  • Morphine sulphate (Drug)
    Morphine, IV

Eligibility criteria

Inclusion Criteria: 1. Age 6 to \< 18 years old 2. Chief complaint includes abdominal pain OR isolated long-bone extremity fracture (suspected or proven) 3. Self-reported pain score of ≥ 6/10 4. Requires IV morphine for analgesia as determined by the treating physician Exclusion Criteria: 1. Weighs more than 81.9 kg 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 conditions requiring use of opioids as an outpatient 7. 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 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. Patients who are breastfeeding 14. Patient or parent/guardian does not speak English or Spanish 15. Patient previously enrolled in this study 16. Known significant or uncontrolled cardiovascular disease 17. Known increased intracranial pressure and/or elevated intraocular pressure 18. Currently taking or having used a monoamine oxidase inhibitor within 14 days 19. Wards of state, foster children, or children in custody

Conditions

Abdominal Pain Isolated Extremity Fracture Pain Pediatrics

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record