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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Toronto
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto
ClinicalTrials.gov Identifier:
NCT01601197
First received: May 13, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Healthy Infants
Immunization
Pain Management
Behavioral: Tactile stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Infant Pain as assessed by the Modified Behavioral Pain Scale [ Time Frame: First 15 seconds after injection ] [ Designated as safety issue: No ]
    assessed from videotaped procedure


Secondary Outcome Measures:
  • Parent rating of infant pain using the Numerical Rating Scale [ Time Frame: first minute after injection ] [ Designated as safety issue: No ]
  • Immunizer rating of infant pain using the Numerical Rating Scale [ Time Frame: first minute after injection ] [ Designated as safety issue: No ]
  • Infant crying time [ Time Frame: duration of crying after injection ] [ Designated as safety issue: No ]
    assessed from videotaped procedure


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601197

Contacts
Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Mary-Ellen Hogan, PharmD 416-978-1466 me.hogan@utoronto.ca

Locations
Canada, Ontario
Dr. Tommy Ho Pediatric Clinic Recruiting
Toronto, Ontario, Canada, M5G 1Z6
Contact: Anna Taddio, PhD    416-978-8822    anna.taddio@utoronto.ca   
Contact: Mary-Ellen Hogan, PharmD    416-978-1466    me.hogan@utoronto.ca   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Anna Taddio, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
ClinicalTrials.gov Identifier: NCT01601197     History of Changes
Other Study ID Numbers: 27518
Study First Received: May 13, 2012
Last Updated: October 23, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
immunization
pain management
infants
tactile stimulation

ClinicalTrials.gov processed this record on September 16, 2014