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

Phase 3

• Conditions: Healthy Infants; Immunization; Pain Management
• Interventions: Behavioral: Tactile stimulation

• Registration Number: NCT01601197
• Lead Sponsor: University of Toronto

Brief 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-13
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-23
• Last Update Posted: 2012-10-24
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

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

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tactile stimulation	Tactile stimulation	Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s)

Primary Outcome Measures

Name	Time	Method
Infant Pain as assessed by the Modified Behavioral Pain Scale	First 15 seconds after injection	assessed from videotaped procedure

Secondary Outcome Measures

Name	Time	Method
Parent rating of infant pain using the Numerical Rating Scale	first minute after injection
Immunizer rating of infant pain using the Numerical Rating Scale	first minute after injection
Infant crying time	duration of crying after injection	assessed from videotaped procedure

Trial Locations

Locations (1)

Dr. Tommy Ho Pediatric Clinic; 🇨🇦 Toronto, Ontario, Canada