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

October 23, 2012 updated by: Anna Taddio, University of Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z6
        • Recruiting
        • Dr. Tommy Ho Pediatric Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tactile stimulation
Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s)
Behavioral: Tactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
NO_INTERVENTION: No tactile stimulation
There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Pain as assessed by the Modified Behavioral Pain Scale
Time Frame: First 15 seconds after injection
assessed from videotaped procedure
First 15 seconds after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent rating of infant pain using the Numerical Rating Scale
Time Frame: first minute after injection
first minute after injection
Immunizer rating of infant pain using the Numerical Rating Scale
Time Frame: first minute after injection
first minute after injection
Infant crying time
Time Frame: duration of crying after injection
assessed from videotaped procedure
duration of crying after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

May 13, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 27518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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