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

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ClinicalTrials.gov Identifier: NCT00954499
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Women's College Hospital

Brief 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?

Condition or disease Intervention/treatment Phase
Pain From Immunization Behavioral: Tactile stimulation added to Standard care Behavioral: Standard care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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.



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

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


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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Janet Probst, Family Practice Nurse, Women's College Hospital
ClinicalTrials.gov Identifier: NCT00954499     History of Changes
Other Study ID Numbers: 2009-0019
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs