A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00924417
First received: June 18, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 18, 2009
June 18, 2009
January 2009
May 2010   (final data collection date for primary outcome measure)
Faces Pain Scale Revised as reported by child [ Time Frame: To be completed 5 minutes after IV placement ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress [ Time Frame: 5 minutes after IV completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department

This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. The study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. Study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Pain
  • Behavioral: Routine Care
    Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
  • Behavioral: Distraction
    Parent given brief information about the cognitive behavioral technique known as distraction. Parent and child then given 3 distraction "toys/tools" to assist with peripheral intravenous line placement.
  • No Intervention: Routine Care
    Parent given brief description of what entails routine care with peripheral IV placement.
    Intervention: Behavioral: Routine Care
  • Experimental: Distraction
    Parent given brief teaching session on concept of distraction, and parent and child given 3 "distraction" toys/tools to assist with peripheral intravenous line placement.
    Intervention: Behavioral: Distraction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 4 - 9
  • Requiring IV placement for medical care in emergency department
  • Child cognitively normal

Exclusion Criteria:

  • No significant chronic medical conditions
  • No IV in past 3 years
Both
4 Years to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00924417
CMRCIRB#2008-13630
Yes
Rachel E Tuuri, MD, Pediatric Emergency Fellow, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Rachel E Tuuri, MD Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Elizabeth Powell, MD, MPH Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP