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

NCT01503060 | Unknown Phase 3

• 1 other identifier: 1000025726
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

pediatrics; Pain; Immunization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of interventions

  At 2,4,6,12 month vaccinations (Visit 1-4)

Study Arms (4)

Group 1

PLACEBO COMPARATOR

* 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; Drug: Sucrose Placebo (water); Drug: Lidocaine Placebo

Group 2

ACTIVE COMPARATOR

* 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; Drug: Sucrose Placebo (water); Drug: Lidocaine Placebo

Group 3

ACTIVE COMPARATOR

* 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; Drug: Sucrose; Drug: Lidocaine Placebo

Group 4

ACTIVE COMPARATOR

* 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; Drug: Sucrose; Drug: Lidocaine

Interventions

Educational video - Active BEHAVIORAL

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

Group 2; Group 3; Group 4

Educational Video - Sham BEHAVIORAL

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

Group 1

Sucrose Placebo (water) DRUG

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

Group 1; Group 2

Sucrose DRUG

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

Group 3; Group 4

Lidocaine Placebo DRUG

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

Group 1; Group 2; Group 3

Lidocaine DRUG

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

Group 4

Eligibility Criteria

• Age: 2 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Healthy infants undergoing vaccination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Outpatient Clinic

Toronto, Ontario, M4V 2S2, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 28455250 DERIVED

• 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.

  PMID: 27956393 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Water; Sucrose; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anna Taddio, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Taddio, PhD

CONTACT

416-813-6235; anna.taddio@sickkids.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist/Pharmacist

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 2, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2016
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

CA (2)