NCT01170247

Brief Summary

The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

July 21, 2010

Results QC Date

March 16, 2017

Last Update Submit

June 3, 2017

Conditions

Sedation

Keywords

Procedural Sedation

Outcome Measures

Primary Outcomes (1)

  • Onset of Sedation

    Minutes it takes until the patient is cooperative enough for the procedure

    Every 60 seconds through study completion

Study Arms (2)

Intranasal Ketamine

EXPERIMENTAL
Drug: Ketamine

Intramuscular Ketamine

ACTIVE COMPARATOR
Drug: Ketamine

Interventions

KetamineDRUG

Intranasal Ketamine (100 mg/mL)

Intranasal Ketamine

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients age 2 to 17 years old
  • have a laceration of 4 cm on the face or 7 cm on the remainder of the body
  • Require procedural sedation to repair the laceration

You may not qualify if:

  • Patients with abnormal nasal physiology which would not allow for adequate medication delivery
  • Unable to have a guardian present to consent on their behalf
  • Allergy to ketamine
  • Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
  • Presenting with a head injury associated with possible intracranial hypertension
  • Pregnancy
  • Lacerations that require repair from a consult service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Brett Faine
Organization
University of Iowa
brett-faine@uiowa.edu
319-310-8067

Study Officials

  • Christopher Hogrefe, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Brett Faine, Pharm.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Andrew Nugent, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Specialist

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 27, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 2, 2017

Results First Posted

July 2, 2017

Record last verified: 2017-06

Locations

US(1)