Ketamine vs Morphine for Acute Pain in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares intravenous sub-dissociative ketamine to intravenous morphine for relief of acute pain due to abdominal pain or isolated long-bone fractures in children aged 6 to under 18. It aims to show non-inferiority of ketamine for reducing pain intensity within the first 2 hours, while also comparing cardiopulmonary adverse events and potential long-term effects on pain function and mental health. The study will monitor adverse events, analgesic use, and patient-reported outcomes during the first week and up to 1–6 months after the ED visit. Participants receive either ketamine or morphine as part of standard analgesia determined by the treating team. Lead sponsor is Columbia University with NICHD and NINDS collaboration, across three pediatric centers.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Davis Children's Hospital
  Sacramento, California, United States Recruiting
• Nemours Children's Hospital
  Wilmington, Delaware, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• Children's Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Not yet recruiting
• Arthur M. Blank Hospital
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Daniel S Tsze, MD, MPH — Columbia University
• Study coordinator: Daniel S Tsze, MD, MPH
• Email: dst2141@cumc.columbia.edu
• Phone: 917-375-2647

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.