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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,010
Sub-dissociative ketamine, IV
Morphine, IV
Children's Hospital Los Angeles
Los Angeles, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
Nemours Children's Hospital
Wilmington, Delaware, United States
Arthur M. Blank Hospital
Atlanta, Georgia, United States
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Pain intensity
Self-reported pain intensity measured using the Verbal Numerical Rating Scale (VNRS). Scored from 0 to 10. A higher score indicates a worse outcome.
Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Adverse events, acute
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).
Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Pain-related function
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.
Time frame: Days 1, 2,3, 7 and 30 after discharge.
Traumatic stress, primary assessment
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.
Time frame: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.
Receipt of rescue analgesia
Number of participants who received a rescue analgesic administered.
Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Desire for same analgesic
Number of participants who would want the same analgesic (i.e., study medication) again in the future.
Time frame: At 240 minutes after completion of study drug administration or when a terminal event occurs
Depth of sedation
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.
Time frame: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Analgesic/opioid use 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
Time frame: Days 1, 2, 3, 7, 30, 90, and 180 after discharge
Missed school or work
Days of missed school or work related to the chief complaint.
Time frame: Day 7, 30, 90, 180 after discharge
Return visit
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
Time frame: Day 7, 30, 90, 180 after discharge
Anxiety
General Anxiety Disorder-7 (GAD-7). Scored from 0 to 21. A higher score indicates a worse outcome.
Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge
Depression
Patient-Reported Outcomes Measurement Information System (PROMIS). Scored from 8 to 40. A higher score indicates a worse outcome.
Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge
Substance use
National Institute on Drug Abuse (NIDA) modified assist tool. Scored from 0 to 360. A higher score indicates a worse outcome.
Time frame: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge
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