Morphine or Ketamine for Analgesia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine hydrochloride
DrugSub-dissociative ketamine, IV
Morphine sulphate
DrugMorphine, IV
Treatment groups
1,010 Participants
are divided into 2 treatment groupsGroup A: Sub-dissociative ketamineExperimental treatment 1 intervention
Group B: MorphineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 occurs2
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 occurs3
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.4
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.Secondary outcomes
1
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 occurs2
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 occurs3
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 occurs4
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 dischargeOther outcomes
1
Global satisfaction
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.
Time frame
Up to 120 minutes after completion of study drug administration or until a terminal event occurs2
Opioid use/misuse
Name, dose and duration of opioids used to calculate total days of use during the elapsed time since last assessment and indication for use
Time frame
Days 30, 90, and 180 after discharge3
Pain catastrophizing
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.
Time frame
Baseline (at time of enrollment) and day 7 after discharge.4
Pain interference
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.
Time frame
Day 7 after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
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