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

NCT ID: NCT00954499

Last Updated: 2011-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-11-30

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.

Conditions

Pain From Immunization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

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

Tactile stimulation

Group Type: EXPERIMENTAL

Tactile stimulation added to Standard care

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Women's College Hospital

Principal Investigators

Anna Taddio, B.Sc.Phm, M.Sc., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Women's College Hospital Family Practice Health Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2009-0019

Identifier Type: -

Identifier Source: org_study_id