drugset / Trial / NCT02519595

Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

NCT02519595 ↗

Phase 4 Completed 182 enrolled Children's Hospital of Michigan
RandomizedParallel-groupQuadruple-blindTreatment

Summary

There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.

Timeline

Start
2010-08
Primary completion
2012-08
Completion
2012-08

Outcome

Missed primary endpoint

registry Ketamine IV 1 mg/kg vs Ketamine IV 1.5 mg/kg vs Ketamine IV 2 mg/kg; p = 0.2; Kruskal-Wallis NCT02519595 ↗

registry Ketamine IV 1 mg/kg vs Ketamine IV 1.5 mg/kg vs Ketamine IV 2 mg/kg; p = 0.09; Kruskal-Wallis NCT02519595 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 1 mg/kg Intravenous
Subject Ketamine Small molecule 1.5 mg/kg Intravenous
Subject Ketamine Small molecule 2 mg/kg Intravenous

Indications

No indication recorded.