Healthy Infants, Immunization, Pain Management
Conditions
Keywords
immunization, pain management, infants, tactile stimulation
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.
Detailed description
Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed. 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.
Interventions
BEHAVIORALTactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Pain as assessed by the Modified Behavioral Pain Scale | First 15 seconds after injection | assessed from videotaped procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | assessed from videotaped procedure |
Countries
Canada
Contacts
Primary ContactAnna Taddio, PhD
Backup ContactMary-Ellen Hogan, PharmD
Outcome results
None listed