Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

Sedation Clinical Trial

Official title:

Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170247
• Other study ID #: 201006786
• Secondary ID: University of Io
• Status: Terminated
• Phase: N/A
• First received: July 21, 2010
• Last updated: December 11, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2012
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Ketamine
Intranasal Ketamine (100 mg/mL)
• Ketamine
Intramuscular Ketamine

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of sedation (Observation Scale of Behavioral Distress-Revised)		Up to 60 minutes	No
Primary	Onset of sedation		Minutes it take until the patient is cooperative enough for th procedure	No
Secondary	Time to awakening		Up to 60 minutes after completion of the procedure	No
Secondary	Time to discharge		From the time when the procedure is completed until the patient is discharged home	No
Secondary	Patient satisfaction survey		Approximately 24 hours after the completion of the procedure	No
Secondary	Healthcare provider satisfaction survey	Rate their satisfaction for the following questions: patient toleration of the medication, onset of sedation, comfort of patient during procedure, and adverse effects.	30 minutes after the procdure	No