Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
Sponsor study identifier
Secondary identifiers
interventional
345
0 countries
N/A
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2010
Actual (reported)June 29, 2010
Actual (reported)April 2011
Actual (reported)April 2011
Actual (reported)Pain of immunization
Infants' and toddlers' pain is assessed by coding videotapes using the FLACC (face, legs, activity, crying and consolability) scale. Patients age 4 and older rate pain using self-report via the Faces Pain Scale Revised.
5 minutes during or immediately after immunizations
Pain from immunization using observational measures
5 minutes immediately following immunization
Treatment satisfaction
5 minutes after immunizations
Immunizations are given with standard care of no pain control
Vibrating device with cold pack held to arm proximal to injections within the same dermatome; caretakers offered and instructed in use of distraction cards.
The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
"Buzzy", the vibrating cold pack, is held in place with a velcro strap or pressed by caretaker or nurse immediately prior and during immunizations. The vibration is activated and the device remains in place during the shot, moving locations if multiple shots are given. Distraction cards with pictures on one side and questions on the other are shown to the child while the caretaker asks the finding and seeking questions on the back.
Amy Baxter, MD
MMJ Labs LLC
First Submitted
June 26, 2010
First Posted
June 29, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain
The identical device without batteries or a cold pack is held in place proximal to the site with a velcro strap or pressed by parent or nurse immediately prior to immunizations. The device remains in place throughout the procedure, moving locations to complete multiple shots.
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Study Completion
April 2011
Actual (reported)Last Updated
June 22, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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