Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute
• Treatments: Ketamine; Morphine

Criteria

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