NCT01601197

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Infants
• Immunization
• Pain Management

Interventions

Type	Name	Description
BEHAVIORAL	Tactile stimulation	Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2012-05-17
• Last updated: 2012-10-24

Locations

1 site across 1 country: Canada