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

The Hospital for Sick Children

Status and phase: Unknown; Phase 3

Conditions: Pain

Treatments: Drug: Lidocaine Placebo; Behavioral: Educational Video - Sham; Drug: Lidocaine; Drug: Sucrose; Drug: Sucrose Placebo (water); Behavioral: Educational video - Active

Study type: Interventional

Funder types: Other

Identifiers

NCT01503060

1000025726

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 2 to 15 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 4 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Sucrose Placebo (water)

Drug: Lidocaine Placebo

Behavioral: Educational Video - Sham

Group 2

Active Comparator group

Description:

* 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.

Treatment:

Drug: Sucrose Placebo (water)

Behavioral: Educational video - Active

Drug: Lidocaine Placebo

Group 3

Active Comparator group

Description:

* 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.

Treatment:

Behavioral: Educational video - Active

Drug: Lidocaine Placebo

Drug: Sucrose

Group 4

Active Comparator group

Description:

* 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.

Treatment:

Behavioral: Educational video - Active

Drug: Lidocaine

Drug: Sucrose