Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503060

Enrollment

352

Registered

2012-01-02

Start date

2011-12-31

Completion date

Unknown

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pediatrics, Pain, Immunization

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.

Interventions

BEHAVIORALEducational video - Active

The active video will instruct parents in techniques related to optimal infant soothing.

BEHAVIORALEducational Video - Sham

The sham video will provide general information about immunization immunization pain management.

DRUGSucrose Placebo (water)

Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

DRUGSucrose

Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

DRUGLidocaine Placebo

Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination

DRUGLidocaine

Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Months to 15 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Hypersensitivity to pain	At 15 month vaccination (Visit 5)	This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months

Secondary

Measure	Time frame	Description
Effectiveness of interventions	At 2,4,6,12 month vaccinations (Visit 1-4)	This will be assessed by comparing the pain scores between groups

Countries

Canada

Contacts

Primary ContactAnna Taddio, PhD

anna.taddio@sickkids.ca416-813-6235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026