This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Kindercare
Toronto, Ontario, Canada
RECRUITINGAnna Taddio
Toronto, Ontario, Canada
NOT_YET_RECRUITINGDistress
Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall
Time frame: immediately after vaccinations in 15 seconds
Distress
Observer rated cry duration after vaccination
Time frame: immediately after vaccinations in 1 minute intervals for 2 minutes
Distress
Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)
Time frame: immediately after vaccinations in 1 minute
Distress
Parent rated distress after each injection using a Numerical Rating Scale (0-10)
Time frame: immediately after vaccinations in 1 minute
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