NCT00954499

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: All
• Age: 4 Months – 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Pain From Immunization

Interventions

Type	Name	Description
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.
BEHAVIORAL	Standard care	* Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-08-07
• Last updated: 2011-03-01

Locations

1 site across 1 country: Canada