Status:
COMPLETED
Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
Lead Sponsor:
Women's College Hospital
Conditions:
Pain From Immunization
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief Summary
The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovir...
Detailed Description
Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain. There are many non-pharmacological methods that...
Eligibility Criteria
Inclusion
- healthy infants
- 4 to 6 months old
- routine immunization with DTaP-IPV-Hib and PCV
Exclusion
- impaired neurological development
- history of seizure
- use of topical local anaesthetics at the injection site
- use of sedatives or narcotics in the preceding 24 hours
- fever or illness that would prevent administration of the vaccine
- parent is unable to use the assessment tools in the study
- parent does not speak English
- prior participation in this trial
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00954499
Start Date
July 1 2009
End Date
November 1 2010
Last Update
March 1 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Women's College Hospital Family Practice Health Centre
Toronto, Ontario, Canada, M5S 1B6