Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Early Phase 1

Terminated

• Conditions: Failed Moderate Sedation During Procedure; Ketamine Adverse Reaction
• Interventions: Drug: Ketamine Hcl 100Mg/Ml Inj

• Registration Number: NCT03067974
• Lead Sponsor: University of Arizona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Study Start: 2017-09-21
• Status Verified: 2019-01
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
• Body weight of 20kg or less (actual, estimated, or measured)
• NPO for four hours or more
• Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.

Exclusion Criteria

• Discretion of parents
• Discretion of provider
• Body weight greater than 20kg (actual, estimated, or measured)
• Starting Aldrete score <9/10
• Known or suspected psychosis
• Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
• Significant elevation in blood pressure
• Known hypersensitivity to ketamine
• Non-English or Spanish speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intranasal ketamine arm	Ketamine Hcl 100Mg/Ml Inj	10mg/kg intranasal ketamine administered one time

Primary Outcome Measures

Name	Time	Method
Successful procedural sedation	The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).	Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

Trial Locations

Locations (1)

Banner Univsersity Medical Center Tucson; 🇺🇸 Tucson, Arizona, United States