NCT03067974

Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

Conditions

• Failed Moderate Sedation During Procedure
• Ketamine Adverse Reaction

Interventions

Type	Name	Description
DRUG	Ketamine Hcl 100Mg/Ml Inj	10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation

Timeline

• Start date: 2017-09-21
• Primary completion: 2019-01-22
• Completion: 2019-01-22
• First posted: 2017-03-01
• Last updated: 2019-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study