A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy Infants
- Sponsor
- University of Toronto
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Infant Pain as assessed by the Modified Behavioral Pain Scale
- Last Updated
- 13 years ago
Overview
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.
Investigators
Anna Taddio
Associate Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
Eligibility Criteria
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
Outcomes
Primary Outcomes
Infant Pain as assessed by the Modified Behavioral Pain Scale
Time Frame: First 15 seconds after injection
assessed from videotaped procedure
Secondary Outcomes
- 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)