Not Yet RecruitingPhase 3ketamine

Morphine or Ketamine for Analgesia

Sponsored by Columbia University

NCT ID
NCT06835504
Target Enrollment
1,010 participants
Start Date
2026-05-01
Est. Completion
2029-10-31

About This Study

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.

Conditions Studied

Abdominal PainIsolated Extremity FracturePainPediatrics

Interventions

  • Ketamine hydrochloride
  • Morphine sulphate

Eligibility

Age:6 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations (8)

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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Daniel S Tsze, MD, MPH
CONTACT
917-375-2647dst2141@cumc.columbia.edu
Amy L Drendel, DO, MS
CONTACT
adrendel@mcw.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

Morphine or Ketamine for Analgesia | Huxley