Morphine or Ketamine for Analgesia

Part of paid clinical trials in Los Angeles, California.

Sponsor
Columbia University
Study ID
NCT06835504
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Abdominal Pain
  • Isolated Extremity Fracture
  • Pain
  • Pediatrics

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine hydrochloride — DRUG
    Sub-dissociative ketamine, IV
  • Morphine sulphate — DRUG
    Morphine, IV

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Aug 30, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
1,010 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-dissociative ketamine
    0.25 mg/kg, maximum dose 25 mg
  • Active Comparator: Morphine
    0.1 mg/kg, maximum dose 8 mg

Primary Outcome Measure

Pain intensity [ Time Frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Deborah Liu, MD
[email protected]
323-660-2450
UC Davis Children's HospitalSacramentoCalifornia95817
Leah Tzimenatos, MD
[email protected]
800-282-3284
Nemours Children's HospitalWilmingtonDelaware19803
Amy Thompson, MD, MSCR
[email protected]
302-651-4200
Arthur M. Blank HospitalAtlantaGeorgia30329
Becky Burger, MD
[email protected]
404-785-5437
Claudia R Morris
[email protected]
NewYork Presbyterian Morgan Stanley Children's HospitalNew YorkNew York10032
Daniel S Tsze, MD, MPH
[email protected]
212-305-6628
Raquel Shrager
[email protected]
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Maren Lunoe, MD
[email protected]
412-692-5325
Bob Hickey, MD
[email protected]
Seattle Children's HospitalSeattleWashington98105
Eileen Klein, MD, MPH
[email protected]
206-987-8811
Children's WisconsinMilwaukeeWisconsin53226
Amy L Drendel, DO, MS
[email protected]
877-266-8989

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAUC Davis Children's Hospital· Sacramento, CANemours Children's Hospital· Wilmington, DEArthur M. Blank Hospital· Atlanta, GANewYork Presbyterian Morgan Stanley Children's Hospital· New York, NYUPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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