Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Failed Moderate Sedation During Procedure Clinical Trial

Official title:

Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03067974
• Other study ID #: 1705414419
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 21, 2017
• Est. completion date: January 22, 2019

Study information

• Verified date: January 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Moderate Sedation During Procedure
• Ketamine Adverse Reaction

Intervention

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

Locations

Country	Name	City	State
United States	Banner Univsersity Medical Center Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).