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Pain-Reduction Techniques for Infant Immunization Pain

Phase 3

Waitlist Available

Led By Anna Taddio, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2,4,6,12 month vaccinations (visit 1-4)

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is testing different ways to ease the pain of routine immunization shots for infants.

Who is the study for?

This trial is for healthy infants getting their routine vaccination shots. Infants born prematurely, those who've had hospital stays or surgery (except right after birth), or have allergies to certain anesthetics or vaccines can't participate. Also, if the mother intends to breastfeed, use sugar water, or topical anesthetics during the shot, the infant isn't eligible.

What is being tested?

The study tests how effective different pain-relief methods are when babies get their shots. It compares using a sweet solution (sucrose) and numbing cream (lidocaine) against placebo versions of these treatments along with educational videos for parents that either contain active advice or sham information.

What are the potential side effects?

Possible side effects may include discomfort at the site where lidocaine is applied and sensitivity reactions in some infants. The sucrose solution is generally safe but could cause mild digestive upset.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2,4,6,12 month vaccinations (visit 1-4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2,4,6,12 month vaccinations (visit 1-4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2,4,6,12 month vaccinations (visit 1-4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hypersensitivity to pain

Secondary study objectives

Effectiveness of interventions

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Group 3Active Control3 Interventions

* 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.

Group II: Group 2Active Control3 Interventions

* 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.

Group III: Group 4Active Control3 Interventions

* 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.

Group IV: Group 1Placebo Group3 Interventions

* 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.

Do I qualify?Apply below to find out