Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

NCT ID: NCT03067974

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2019-01-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal ketamine arm

10mg/kg intranasal ketamine administered one time

Group Type: EXPERIMENTAL

Ketamine Hcl 100Mg/Ml Inj

Intervention Type: DRUG

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

Interventions

Ketamine Hcl 100Mg/Ml Inj

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Vivienne Ng

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vivienne Ng, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Banner Univsersity Medical Center Tucson

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1705414419

Identifier Type: -

Identifier Source: org_study_id