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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00924417
• Other study ID #: CMRCIRB#2008-13630
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Routine care patients will have intravenous lines placed in the usual manner.

Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Pain

Intervention

Behavioral:
• Routine Care
Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
• 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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faces Pain Scale Revised as reported by child		To be completed 5 minutes after IV placement
Secondary	Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress		5 minutes after IV completion