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Completed

NCT Number: NCT00954499

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

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?

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Key information

Conditions

Pain From Immunization Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital Family Practice Health Centre

Toronto, Ontario, M5S 1B6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tactile stimulation added to Standard care

Behavioral
  • 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.

Standard Care

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

Primary outcomes

  1. Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).

    Time frame: at time of injection on day 1

Secondary outcomes

  1. Pain response to immunization as measured by observer Visual Analogue Scale (VAS).

    Time frame: at time of injection on day 1

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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