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Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Trauma Clinical Trial

Official title:
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Clinical Trial Summary

This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.

Clinical Trial Description

The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03781817
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Terminated
Phase Phase 4
Start date September 9, 2019
Completion date April 30, 2022
View Details
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