Summary

Eligibility
for people ages 6-17 (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children with Acute Pain

Details

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, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events 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.

Keywords

Abdominal Pain, Isolated Extremity Fracture, Pain, Pediatrics, Ketamine, Morphine, Pediatric, Children, Sub-dissociative, Opioid-sparing, Emergency medicine, Emergency care, Emergency department, Post-traumatic stress, Anxiety, Depression, Fracture, Analgesia, Ketamine hydrochloride, Morphine sulphate, Sub-dissociative ketamine

Eligibility

You can join if…

Open to people ages 6-17

  1. Abdominal pain or isolated long-bone extremity fracture (suspected or proven)
  2. Self-reported pain score of ≥ 6/10
  3. Requires IV morphine for analgesia as determined by the treating physician

You CAN'T join if...

  1. Weight > 82.4 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 condition requiring use of opioids as outpatient
  7. Hemodynamic instability or critical illness per treating physician
  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. Does not speak English or Spanish
  14. Patient previously enrolled in this study
  15. Wards of state, foster children, or children in custody

Locations

  • UC Davis Children's Hospital
    Sacramento California 95817 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Columbia University
ID
NCT06835504
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1010 study participants
Last Updated