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

Women's College Hospital

Status: Completed

Conditions: Pain From Immunization

Treatments: Behavioral: Tactile stimulation added to Standard care; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT00954499

2009-0019

Details and patient eligibility

About

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?

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Standard care

Active Comparator group

Treatment:

Behavioral: Standard care

Tactile stimulation

Experimental group

Treatment:

Behavioral: Tactile stimulation added to Standard care