Vaccination Pain Management
Conditions
Keywords
vaccination, pain management, sucrose, rotavirus
Brief summary
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.
Interventions
DRUGSucrose
Sucrose 24% orally prior to vaccine injections
DRUGRotavirus
Rotavirus vaccine orally prior to vaccine injections
Sponsors
Anna Taddio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life
Exclusion criteria
* impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distress | immediately after vaccinations in 15 seconds | Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress | immediately after vaccinations in 1 minute intervals for 2 minutes | Observer rated cry duration after vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | immediately after vaccinations in 5 minutes | Number of infants spitting up/gagging with administration of study liquid |
| Satisfaction | immediately after vaccination in 1 minute | Parent rated satisfaction with pain control using likert scale |
Countries
Canada
Contacts
Primary ContactAnna Taddio, PhD
Backup ContactMoshe Ipp, MD
Outcome results
None listed