drugset / Trial / NCT01951963

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

NCT01951963 ↗

Phase 4 Completed 77 enrolled HealthPartners Institute
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-12
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.3 mg/kg Intravenous
Comparator Morphine Other / unclassified 0.05 mg/kg Intravenous

Indications

No indication recorded.