A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
1 other identifier
interventional
120
1 country
1
Brief Summary
Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedOctober 24, 2012
October 1, 2012
7 months
May 13, 2012
October 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infant Pain as assessed by the Modified Behavioral Pain Scale
assessed from videotaped procedure
First 15 seconds after injection
Secondary Outcomes (3)
Parent rating of infant pain using the Numerical Rating Scale
first minute after injection
Immunizer rating of infant pain using the Numerical Rating Scale
first minute after injection
Infant crying time
duration of crying after injection
Study Arms (2)
Tactile stimulation
EXPERIMENTALIpsilateral limb will be rubbed immediately before, during and after immunization injection(s)
No tactile stimulation
NO INTERVENTIONThere will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s)
Interventions
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
Eligibility Criteria
You may qualify if:
- infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto
You may not qualify if:
- impaired neurological development
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Tommy Ho Pediatric Clinic
Toronto, Ontario, M5G 1Z6, Canada
Related Publications (1)
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.
PMID: 24634424DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Taddio, PhD
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Leslie Dan Faculty of Pharmacy
Study Record Dates
First Submitted
May 13, 2012
First Posted
May 17, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
October 24, 2012
Record last verified: 2012-10