A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization

Pain Management Clinical Trial

Official title:

A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01601197
• Other study ID #: 27518
• Status: Recruiting
• Phase: Phase 3
• First received: May 13, 2012
• Last updated: October 23, 2012
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-978-8822
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.

Description:

Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed.

Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.

The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

• infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto

Exclusion Criteria:

• impaired neurological development

• history of seizure

• use of topical anesthetics

• use of sedatives or narcotics within 24 hours

• fever or illness that would prevent administration of vaccine

• prior participation in the trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Infants
• Immunization
• Pain Management

Intervention

Behavioral:
• Tactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)

Locations

Country	Name	City	State
Canada	Dr. Tommy Ho Pediatric Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Pain as assessed by the Modified Behavioral Pain Scale	assessed from videotaped procedure	First 15 seconds after injection	No
Secondary	Parent rating of infant pain using the Numerical Rating Scale		first minute after injection	No
Secondary	Immunizer rating of infant pain using the Numerical Rating Scale		first minute after injection	No
Secondary	Infant crying time	assessed from videotaped procedure	duration of crying after injection	No