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Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach

NCT00954499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-03-01

No results posted yet for this study

Summary

The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions (least painful injection technique, holding by parent, and oral sucrose solution) and non-procedural talk by the parent, does the addition of rubbing near the site of injection reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than no rubbing?

Conditions

  • Pain From Immunization

Interventions

BEHAVIORAL

Tactile stimulation added to Standard care

* Parent rubs the infant's skin near the injection site just before, during and after the injection. * Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close.

BEHAVIORAL

Standard care

* Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close.

Sponsors & Collaborators

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Anna Taddio, B.Sc.Phm, M.Sc., Ph.D. · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00954499 on ClinicalTrials.gov