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

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Immunization; Pain Management; Healthy Infants

Treatments: Behavioral: Tactile stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01601197

27518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Tactile stimulation

Experimental group

Description:

Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s)

Treatment:

Behavioral: Tactile stimulation

No tactile stimulation

No Intervention group

Description:

There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s)