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

February 28, 2011 updated by: Women's College Hospital
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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain.

There are many non-pharmacological methods that can be used to reduce immunization pain. These include: sugar water, fast injection without aspiration, holding infants during the procedure, and non-procedural related parental behaviours such as distraction. At present, there are no studies of tactile stimulation during noxious procedures in infants and its effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that is administered by a parent immediately before, during and immediately after immunization is an easily learned, cost neutral intervention that could offer improved pain management.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B6
        • Women's College Hospital Family Practice Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy infants
  • 4 to 6 months old
  • routine immunization with DTaP-IPV-Hib and PCV

Exclusion Criteria:

  • impaired neurological development
  • history of seizure
  • use of topical local anaesthetics at the injection site
  • use of sedatives or narcotics in the preceding 24 hours
  • fever or illness that would prevent administration of the vaccine
  • parent is unable to use the assessment tools in the study
  • parent does not speak English
  • prior participation in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
Behavioral: Standard care
  • Fast injection technique without aspiration.
  • Oral sucrose 2 minutes before first injection.
  • Parent holds infant close.
Experimental: Tactile stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).
Time Frame: at time of injection on day 1
at time of injection on day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain response to immunization as measured by observer Visual Analogue Scale (VAS).
Time Frame: at time of injection on day 1
at time of injection on day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Investigators

  • Principal Investigator: Anna Taddio, B.Sc.Phm, M.Sc., Ph.D., University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009-0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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