Clinical trial NCT01601197: A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
Official title: A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy Infants
Immunization
Pain Management
Keywords: immunization
pain management
infants
tactile stimulation
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Infant Pain as assessed by the Modified Behavioral Pain Scale
timeFrame: First 15 seconds after injection
Secondary outcomes:
measure: Parent rating of infant pain using the Numerical Rating Scale
timeFrame: first minute after injection
measure: Immunizer rating of infant pain using the Numerical Rating Scale
timeFrame: first minute after injection
measure: Infant crying time
timeFrame: duration of crying after injection
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr. Tommy Ho Pediatric Clinic
state: Ontario
Study officials:
affiliation: Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.