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

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ClinicalTrials.gov Identifier: NCT01503060
Recruitment Status : Unknown
Verified November 2015 by Anna Taddio, The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : January 2, 2012
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Educational video - Active Behavioral: Educational Video - Sham Drug: Sucrose Placebo (water) Drug: Sucrose Drug: Lidocaine Placebo Drug: Lidocaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
Study Start Date : December 2011
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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.
Behavioral: Educational Video - Sham
The sham video will provide general information about immunization immunization pain management.

Drug: Sucrose Placebo (water)
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

Drug: 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

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.
Behavioral: Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.

Drug: Sucrose Placebo (water)
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

Drug: 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

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.
Behavioral: Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.

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

Drug: 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

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.
Behavioral: Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.

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

Drug: 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 Measures :
  1. Hypersensitivity to pain [ Time Frame: 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 Outcome Measures :
  1. Effectiveness of interventions [ Time Frame: At 2,4,6,12 month vaccinations (Visit 1-4) ]
    This will be assessed by comparing the pain scores between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503060


Contacts
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Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@sickkids.ca

Locations
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Canada, Ontario
Outpatient Clinic Recruiting
Toronto, Ontario, Canada, M4V 2S2
Contact: Moshe Ipp, MD    (416) 924-7171    moshe.ipp@sickkids.ca   
Principal Investigator: Moshe Ipp, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Contact: Anna Taddio, PhD         
Principal Investigator: Anna Taddio, PhD         
Sub-Investigator: Moshe Ipp, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Taddio, Adjunct Scientist/Pharmacist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01503060     History of Changes
Other Study ID Numbers: 1000025726
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Anna Taddio, The Hospital for Sick Children:
pediatrics
Pain
Immunization
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Lidocaine
Vaccines
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors