Recruiting
Phase 3

Ketamine vs. Morphine

Sponsor:

Columbia University

Code:

NCT06835504

Conditions

Abdominal Pain

Isolated Extremity Fracture

Pain

Pediatrics

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Ketamine hydrochloride

Morphine sulphate

Study Details

Brief 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.

Conditions

Abdominal Pain

Isolated Extremity Fracture

Pain

Pediatrics

Study ID

NCT06835504

Start date

Oct 17, 2026

Status verified date

Oct, 2026

Completion date

Apr 23, 2030

Anticipated

Primary completion date

Apr 23, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

1010 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-dissociative ketamine

0.25 mg/kg

active comparator: Morphine

0.1 mg/kg

Interventions

Ketamine hydrochloride

Sub-dissociative ketamine, IV

Morphine sulphate

Morphine, IV

Primary outcome measure

  • Pain intensity [ Time Frame: Up to 240 minutes after completion of study drug administration or until a terminal event occurs ]
  • Cardiopulmonary adverse events requiring an intervention [ Time Frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs ]
  • Pain-related function [ Time Frame: Days 1, 2,3, and 7 after discharge. ]
  • Post-traumatic stress [ Time Frame: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge. ]

Central Contacts and Locations

Central contacts

Amy L Drendel, DO, MS

adrendel@mcw.edu

Locations

UC Davis Children's Hospital

Recruiting

Sacramento, California, United States, 95817

Contacts

Nemours Children's Hospital

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Amy L Drendel, DO, MS

877-266-8989adrendel@mcw.edu

More Information

Sponsor

Columbia University

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Ketamine
  • Morphine
  • Pediatric
  • Children
  • Sub-dissociative
  • Opioid-sparing
  • Emergency medicine
  • Emergency care
  • Emergency department
  • Post-traumatic stress
  • Anxiety
  • Depression
  • Abdominal pain
  • Fracture
  • Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.