NCT03781817

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Intravenous Ketamine	Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
DRUG	Intranasal Ketamine	Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Timeline

• Start date: 2019-09-09
• Primary completion: 2022-01-21
• Completion: 2022-04-30
• First posted: 2018-12-20
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study