Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
NCT ID: NCT01503060
Last Updated: 2015-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
352 participants
INTERVENTIONAL
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group 1
* Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Educational Video - Sham
The sham video will provide general information about immunization immunization pain management.
Sucrose Placebo (water)
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine Placebo
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Group 2
* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.
Sucrose Placebo (water)
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine Placebo
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Group 3
* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.
Sucrose
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine Placebo
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Group 4
* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.
Sucrose
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Interventions
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Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.
Educational Video - Sham
The sham video will provide general information about immunization immunization pain management.
Sucrose Placebo (water)
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Sucrose
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine Placebo
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Lidocaine
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. prior hospitalization/surgery (other than postnatal care),
3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
2 Months
15 Months
ALL
Yes
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Anna Taddio
Adjunct Scientist/Pharmacist
Principal Investigators
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Anna Taddio, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Outpatient Clinic
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Anna Taddio, PhD
Role: primary
References
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Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.
Other Identifiers
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1000025726
Identifier Type: -
Identifier Source: org_study_id
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