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NCT Number: NCT06835504

Morphine or Ketamine for Analgesia

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.

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Key information

Conditions

Abdominal Pain Agnosia Anxiety Disorders Behavior Behavioral Symptoms Depression Disease Attributes Emergencies Fractures, Bone Isolated Extremity Fracture Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatrics Perceptual Disorders Signs and Symptoms Signs and Symptoms, Digestive Wounds and Injuries

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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About this study

Aim 1: To determine if IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children presenting to an ED with acute pain. The investigators hypothesize that IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children with acute abdominal pain or an extremity fracture.

Aim 2: To compare the rate of acute (<2 hours) adverse events, including cardiopulmonary adverse events, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events associated with IV sub-dissociative ketamine compared to IV morphine.

Aim 3: To determine the relationship between ketamine and long-term sequelae of acute pain. The investigators hypothesize that children who receive ketamine will have better levels of pain-related function during the first week following ED presentation and will have greater odds of experiencing more favorable post-traumatic stress, anxiety and depression outcomes 1-6 months after ED presentation compared to children who received IV morphine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Abdominal pain or isolated long-bone extremity fracture (suspected or proven)
  • Self-reported pain score of ≥ 6/10
  • Requires IV morphine for analgesia as determined by the treating physician

Exclusion criteria

  • Weight > 82.4 kg
  • Known allergy/contraindication to morphine or ketamine
  • Antecedent receipt of ketamine related to presenting complaint
  • Inability to use self-report measures of pain or questionnaires
  • Chronic disease associated with pain
  • Chronic pain condition requiring use of opioids as outpatient
  • Hemodynamic instability or critical illness per treating physician
  • Altered mental state (e.g., GCS , 14 or clinical intoxication)
  • Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta
  • Concern for open fracture, neurovascular compromise, or compartment syndrome
  • Injuries in addition to the extremity injury (e.g., head, neck, abdomen)
  • Known or reported pregnancy
  • Does not speak English or Spanish
  • Patient previously enrolled in this study
  • Wards of state, foster children, or children in custody

Treatment and study plan

Ketamine Hydrochloride

Drug

Sub-dissociative ketamine, IV

Morphine sulphate

Drug

Morphine, IV

Primary outcomes

  1. Pain intensity

    Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs

    Self-reported pain intensity measured using the Verbal Numerical Rating Scale (VNRS). Scored from 0 to 10. A higher score indicates a worse outcome.

  2. Adverse events, acute

    Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs

    Examples of adverse events include, but are not limited to, cardiopulmonary adverse events (e.g., hypoxia, respiratory depression, hypotension); opioid-related adverse events; and adverse events as measured using the Side Effects Rating Scale of Dissociative Anesthetics (SERSDA).

  3. Pain-related function

    Time frame: Days 1, 2,3, 7 and 30 after discharge.

    Pain intensity and related functional limitations due to pain, measured using the Parents' Postoperative Pain Measure (PPPM). Scored from 0 to 10. A higher score indicates a worse outcome.

  4. Traumatic stress, primary assessment

    Time frame: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.

    Stress related to the pain experienced measured using the Child Stress Disorder Checklist (CSDC-SF). Scored from 0 to 8. A higher score indicates a worse outcome.

Secondary outcomes

  1. Receipt of rescue analgesia

    Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs

    Number of participants who received a rescue analgesic administered.

  2. Desire for same analgesic

    Time frame: At 240 minutes after completion of study drug administration or when a terminal event occurs

    Number of participants who would want the same analgesic (i.e., study medication) again in the future.

  3. Depth of sedation

    Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs

    Depth of sedation measured using the University of Michigan Sedation Scale (UMSS). Scored from 0 to 4. 0 is deepest level of sedation (unarousable), 4 is awake and alert.

  4. Analgesic/opioid use after discharge

    Time frame: Days 1, 2, 3, 7, 30, 90, and 180 after discharge

    Name, dose and duration of analgesics and/or opioids used to calculate total days of use during the elapsed time since last assessment

  5. Missed school or work

    Time frame: Day 7, 30, 90, 180 after discharge

    Days of missed school or work related to the chief complaint.

  6. Return visit

    Time frame: Day 7, 30, 90, 180 after discharge

    Number of return visits related to the chief complaint, which can include (but not limited to) return visits to the emergency department or primary care physician

  7. Anxiety

    Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge

    General Anxiety Disorder-7 (GAD-7). Scored from 0 to 21. A higher score indicates a worse outcome.

  8. Depression

    Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge

    Patient-Reported Outcomes Measurement Information System (PROMIS). Scored from 8 to 40. A higher score indicates a worse outcome.

  9. Substance use

    Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge

    National Institute on Drug Abuse (NIDA) modified assist tool. Scored from 0 to 360. A higher score indicates a worse outcome.

Other outcomes

  1. Global satisfaction

    Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs

    Global satisfaction with analgesia measured using the Patient Global Impression of Change (PGIC) score. Scored from 1 to 7. A higher score indicates a worse outcome.

  2. Opioid use/misuse

    Time frame: Days 30, 90, and 180 after discharge

    Name, dose and duration of opioids used to calculate total days of use during the elapsed time since last assessment and indication for use

  3. Pain catastrophizing

    Time frame: Baseline (at time of enrollment) and day 7 after discharge.

    Assessment of heightened negative cognitive and affective pain responses in children. Measured using the Pain Catastrophizing Scale (PCS) for Children. Scored from 0 to 4. A higher score indicates more catastrophizing.

  4. Pain interference

    Time frame: Day 7 after discharge

    How much pain interferes with daily activities measured using the Brief Pain Inventory (BPI) Pain Interference. Scored from 0 to 10. A higher score indicates a worse outcome.

  5. Physical functioning

    Time frame: Baseline (at time of enrollment) and day 7 after discharge

    Health related quality of life measured using the Pediatric Quality of Life (PedsQL) inventory. Scored from 0 to 100. A higher score indicates a better health-related quality of life.

  6. Sleep

    Time frame: Baseline (at time of enrollment) and day 7 after discharge

    Impact of pain on sleep measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance 8a + sleep duration. Scored from 8 to 40. A higher score indicates a worse outcome.

  7. Traumatic stress, secondary assessment

    Time frame: Days 7, 30, 90, and 180 after discharge.

    University of California Los Angeles Post-Traumatic Stress Disorder (UCLA PTSD). Scored from 0 to 108. A higher score indicates a worse outcome.

  8. Parent/Guardian/Caregiver Pain Catastrophizing

    Time frame: Day 180 after discharge

    Pain Catastrophizing Scale (PCS) for Parents. Scored from 0 to 52. A higher score indicates a worse outcome.

  9. Parent/Guardian/Caregiver Pain Depression

    Time frame: Day 180 after discharge.

    Patient Health Questionnaire-2 (PHQ-2). Scored from 0 to 6. If the score is 3 or greater, major depressive disorder is likely.

  10. Parent/Guardian/Caregiver Pain Anxiety

    Time frame: Day 180 after discharge

    Generalized Anxiety Disorder 2-item (GAD-2). Scored from 0 to 6. A higher score indicates a worse outcome.

  11. Parent/Guardian/Caregiver Pain Quality of Life

    Time frame: Day 180 after discharge

    World Health Organization Quality of Life-2 item (WHOQOL-2). Scored from 2 to 10. A higher score indicates a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy L Drendel, DO, MS

CONTACT

[email protected]

Daniel S Tsze, MD, MPH

CONTACT

[email protected]

917-375-2647

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: MoKA

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 19, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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