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Morphine or Ketamine for Analgesia

Morphine or Ketamine for Analgesia

Recruiting
6-17 years
All
Phase 3

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Overview

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.

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.

Eligibility

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

Study details
    Abdominal Pain
    Isolated Extremity Fracture
    Pain
    Pediatrics

NCT06835504

Columbia University

21 October 2026

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