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

Not Applicable

Completed

• Conditions: Pain From Immunization
• Interventions: Behavioral: Standard care; Behavioral: Tactile stimulation added to Standard care

• Registration Number: NCT00954499
• Lead Sponsor: 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?

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-28
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	-
Tactile stimulation	Tactile stimulation added to Standard care	-

Primary Outcome Measures

Name	Time	Method
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).	at time of injection on day 1

Secondary Outcome Measures

Name	Time	Method
Pain response to immunization as measured by observer Visual Analogue Scale (VAS).	at time of injection on day 1

Trial Locations

Locations (1)

Women's College Hospital Family Practice Health Centre; 🇨🇦 Toronto, Ontario, Canada