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

Ketamine

Brief Summary

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

Intervention / Treatment

  • Drug: Intravenous Ketamine
  • Drug: intranasal ketamine

Condition or Disease

  • Trauma
  • Fractures, Closed
  • Children, Only
  • Deep Sedation
  • Ketamine

Phase

Study Design

Study type: Interventional
Status: Suspended
Study results: No Results Available
Age: 1 Year to 18 Years   (Child, Adult)
Enrollment: 70 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Sep 09, 2019
Primary Completion: Jan 21, 2022
Completion Date: Apr 30, 2022
Study First Posted: Dec 20, 2018
Results First Posted: Aug 31, 2020
Last Updated: Feb 25, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Birmingham, Alabama, USA

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.

Eligibility Criteria

Sex: All
Minimum Age: 1
Maximum Age: 18

More Details

NCT Number: NCT03781817
Other IDs: IRB-300002731
Study URL: https://ClinicalTrials.gov/show/NCT03781817
Last updated: Jun 17, 2022