Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Study Overview
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Brief Summary
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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.

Official Title
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Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Ketamine, single dose, 0.3 mg/kg, IV | Drug: Ketamine<br> <br> |
| Active Comparator: Morphine<br>Morphine, single dose, 0.05 mg/kg, IV | Drug: Morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Narcotic Consumption | All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results. | 3 hours post study drug administration | 
| Adverse Drug Reaction | Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form. | 3 hours post study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, ketamine, morphine, pediatrics, emergency medicine