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

NCT01601197 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-10-24

No results posted yet for this study

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.

Conditions

  • Healthy Infants
  • Immunization
  • Pain Management

Interventions

BEHAVIORAL

Tactile stimulation

Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Anna Taddio, PhD · Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01601197 on ClinicalTrials.gov