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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Behavioral: Educational Video - Sham; Drug: Sucrose Placebo (water); Drug: Lidocaine Placebo; Behavioral: Educational video - Active; Drug: Sucrose; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Anna Taddio, PhD
      • Principal Investigator: Anna Taddio, PhD
      • Sub-Investigator: Moshe Ipp, MD
    • Toronto, Ontario, Canada, M4V 2S2
      • Recruiting
      • Outpatient Clinic
      • Contact: Moshe Ipp, MD; Phone Number: (416) 924-7171; Email: moshe.ipp@sickkids.ca
      • Principal Investigator: Moshe Ipp, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Anna Taddio, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
• Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimate): January 2, 2012

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: pediatrics; Pain; Immunization
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1000025726