A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
NCT ID: NCT01601197
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2012-05-31
2013-05-31
Brief Summary
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Detailed Description
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Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.
The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tactile stimulation
Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s)
Tactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
No tactile stimulation
There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s)
No interventions assigned to this group
Interventions
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Tactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of seizure
* use of topical anesthetics
* use of sedatives or narcotics within 24 hours
* fever or illness that would prevent administration of vaccine
* prior participation in the trial
1 Month
12 Months
ALL
Yes
Sponsors
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University of Toronto
OTHER
Responsible Party
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Anna Taddio
Associate Professor, Leslie Dan Faculty of Pharmacy
Principal Investigators
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Anna Taddio, PhD
Role: PRINCIPAL_INVESTIGATOR
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada
Locations
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Dr. Tommy Ho Pediatric Clinic
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Anna Taddio, PhD
Role: primary
Mary-Ellen Hogan, PharmD
Role: backup
References
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Taddio A, Ho T, Vyas C, Thivakaran S, Jamal A, Ilersich AF, Hogan ME, Shah V. A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants. Clin Pediatr (Phila). 2014 Jun;53(7):639-44. doi: 10.1177/0009922814526976. Epub 2014 Mar 14.
Other Identifiers
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27518
Identifier Type: -
Identifier Source: org_study_id