Recruiting
Phase 3

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT01503060

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Educational video - Active

Educational Video - Sham

Sucrose Placebo (water)

Sucrose

Lidocaine Placebo

Study Details

Brief summary:

The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.

Conditions

Pain

Study ID

NCT01503060

Start date

Dec, 2011

Status verified date

Nov, 2015

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

1. preterm birth (<37 weeks gestation)
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.

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: 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.

active comparator: 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.

active comparator: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Hypersensitivity to pain [ Time Frame: At 15 month vaccination (Visit 5) ]

Central Contacts and Locations

Central contacts

Anna Taddio, PhD

416-813-6235anna.taddio@sickkids.ca

Locations

Outpatient Clinic

Recruiting

Toronto, Ontario, Canada, M4V 2S2

Contacts

Moshe Ipp, MD

(416) 924-7171moshe.ipp@sickkids.ca

Principal Investigator:

Moshe Ipp, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5V1X8

Principal Investigator:

Anna Taddio, PhD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Nov 10, 2015

Last verified

Nov, 2015

Keywords

  • pediatrics
  • Pain
  • Immunization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2015-11-10.