RightFit
Not yet recruitingPhase 3

Morphine or Ketamine for Analgesia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether low-dose ketamine relieves sudden pain as well as morphine in children in the emergency department. It is for children ages 6 to 17 with belly pain or a possible or confirmed arm or leg fracture, and it will also compare side effects and longer-term health outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 6 to 17.
  • Has belly pain or a possible or confirmed break in a long bone of an arm or leg, with no other injury.
  • Rates their pain as 6 or higher out of 10.
  • A doctor decides they need morphine through an IV, a small tube in a vein.

Who can't join

  • Weighs more than 81.9 kg (about 181 pounds); is allergic to morphine or ketamine or cannot safely take them; or already received ketamine for this problem.
  • Cannot answer pain questions or study forms; the child or parent/guardian does not speak English or Spanish; or the child has already joined this study.
  • Has a long-term disease linked to pain, or ongoing pain that needs opioid medicines at home.
  • Has low oxygen levels (below 92%), breathing rate, heart rate, or blood pressure; is not fully alert; or has serious or uncontrolled heart or blood vessel disease.
  • Has schizophrenia, liver or kidney problems, or brittle bone disease; or has high pressure inside the skull or eyes.
  • May have a broken bone with an open wound, damaged nerves or blood flow, or dangerous pressure inside a muscle; or has injuries besides the arm or leg injury.
  • Is pregnant or breastfeeding, or takes or has taken an MAOI (a type of medicine for depression) in the past 14 days.
  • Is in state care, foster care, or custody.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (8)

CA

DE

GA

NY

PA

WA

WI