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

This study has been completed.
Sponsor:
Information provided by:
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT00954499
First received: July 22, 2009
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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?


Condition Intervention
Pain From Immunization
Behavioral: Tactile stimulation added to Standard care
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach

Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS). [ Time Frame: at time of injection on day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain response to immunization as measured by observer Visual Analogue Scale (VAS). [ Time Frame: at time of injection on day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954499

Locations
Canada, Ontario
Women's College Hospital Family Practice Health Centre
Toronto, Ontario, Canada, M5S 1B6
Sponsors and Collaborators
Women's College Hospital
Investigators
Principal Investigator: Anna Taddio, B.Sc.Phm, M.Sc., Ph.D. University of Toronto
  More Information

No publications provided

Responsible Party: Janet Probst, Family Practice Nurse, Women's College Hospital
ClinicalTrials.gov Identifier: NCT00954499     History of Changes
Other Study ID Numbers: 2009-0019
Study First Received: July 22, 2009
Last Updated: February 28, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Women's College Hospital:
tactile stimulation
pain
immunization
infant

ClinicalTrials.gov processed this record on September 16, 2014