Clinical trial NCT00954499: Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
Official title: Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain From Immunization
Keywords: tactile stimulation
pain
immunization
infant
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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 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

Primary outcomes:
measure: Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).
timeFrame: at time of injection on day 1
Secondary outcomes:
measure: Pain response to immunization as measured by observer Visual Analogue Scale (VAS).
timeFrame: at time of injection on day 1
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital Family Practice Health Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, B.Sc.Phm, M.Sc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: