Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age: 3-17 years old
- Condition (medical or trauma) requiring opioid pain management per standard of care
- Need to establish an IV per standard of care
- Treating physician agrees to manage the patient's pain with morphine following randomization.
Exclusion criteria
- Trauma Team Activation
- Known allergy to ketamine
- Family member unable/unavailable to provide informed consent
- When appropriate, patient unwilling to provide assent
- High suspicion of injury related to child abuse
- Patient and/or family member is non-English speaking
- Patient is incarcerated
Trial design
Primary purpose
Allocation
Interventional model
Masking
77 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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