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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Educational video - Active
* Behavioral: Educational Video - Sham
* Drug: Sucrose Placebo (water)
* Drug: Sucrose
* Drug: Lidocaine Placebo
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Healthy infants undergoing vaccination. Exclusion Criteria: preterm birth (<37 weeks gestation) prior hospitalization/surgery (other than postnatal care), documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines, mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>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. | Behavioral: Educational Video - Sham<br>* The sham video will provide general information about immunization immunization pain management.<br>Drug: Sucrose Placebo (water)<br>* Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination<br>Drug: Lidocaine Placebo<br>* Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination<br>|
| Active Comparator: Group 2<br>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. | Behavioral: Educational video - Active<br>* The active video will instruct parents in techniques related to optimal infant soothing.<br>Drug: Sucrose Placebo (water)<br>* Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination<br>Drug: Lidocaine Placebo<br>* Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination<br>|
| Active Comparator: Group 3<br>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. | Behavioral: Educational video - Active<br>* The active video will instruct parents in techniques related to optimal infant soothing.<br>Drug: Sucrose<br>* Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination<br>Drug: Lidocaine Placebo<br>* Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination<br>|
| Active Comparator: Group 4<br>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. | Behavioral: Educational video - Active<br>* The active video will instruct parents in techniques related to optimal infant soothing.<br>Drug: Sucrose<br>* Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination<br>Drug: Lidocaine<br>* Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Pain, Immunization