Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

NCT03067974 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 1705414419
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Moderate Sedation During Procedure; Ketamine Adverse Reaction

Keywords

ketamine; pediatric; procedural sedation

Outcome Measures

Primary Outcomes (1)

• Successful procedural sedation

  Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

  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).

Study Arms (1)

Intranasal ketamine arm

EXPERIMENTAL

10mg/kg intranasal ketamine administered one time

Drug: Ketamine Hcl 100Mg/Ml Inj

Interventions

Ketamine Hcl 100Mg/Ml Inj DRUG

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

Intranasal ketamine arm

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner Univsersity Medical Center Tucson

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Vivienne Ng, MD, MPH

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Children who meet inclusion and exclusion criteria will be approached for participation in the study.

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: March 1, 2017
• Study Start: September 21, 2017
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)