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Rotavirus vs. Sucrose for Vaccine Injection Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174705
Recruitment Status : Unknown
Verified August 2014 by Anna Taddio, University of Toronto.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

Brief Summary:
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.

Condition or disease Intervention/treatment Phase
Vaccination Pain Management Drug: Sucrose Drug: Rotavirus Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
Study Start Date : June 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Experimental: Sucrose
Sucrose prior to vaccine injections
Drug: Sucrose
Sucrose 24% orally prior to vaccine injections

Active Comparator: Rotavirus
Rotavirus prior to vaccine injections
Drug: Rotavirus
Rotavirus vaccine orally prior to vaccine injections




Primary Outcome Measures :
  1. Distress [ Time Frame: immediately after vaccinations in 15 seconds ]
    Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall


Secondary Outcome Measures :
  1. Distress [ Time Frame: immediately after vaccinations in 1 minute intervals for 2 minutes ]
    Observer rated cry duration after vaccination

  2. Distress [ Time Frame: immediately after vaccinations in 1 minute ]
    Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)

  3. Distress [ Time Frame: immediately after vaccinations in 1 minute ]
    Parent rated distress after each injection using a Numerical Rating Scale (0-10)


Other Outcome Measures:
  1. Safety [ Time Frame: immediately after vaccinations in 5 minutes ]
    Number of infants spitting up/gagging with administration of study liquid

  2. Satisfaction [ Time Frame: immediately after vaccination in 1 minute ]
    Parent rated satisfaction with pain control using likert scale



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life

Exclusion Criteria:

  • impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174705


Contacts
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Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Moshe Ipp, MD 416-924-7171 mm.ipp@utoronto.ca

Locations
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Canada, Ontario
Kindercare Recruiting
Toronto, Ontario, Canada, M5N 1A8
Contact: Dan Flanders, MD    (416) 848-7665      
Contact: Anna Taddio, PhD    416-978-8822    anna.taddio@utoronto.ca   
Principal Investigator: Dan Flanders, MD         
Anna Taddio Not yet recruiting
Toronto, Ontario, Canada, M5S 3M2
Contact: Anna Taddio, PhD    416-978-8822    anna.taddio@utoronto.ca   
Principal Investigator: Dan Flanders, MD         
Sponsors and Collaborators
Anna Taddio
Investigators
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Principal Investigator: Anna Taddio, PhD University of Toronto
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Responsible Party: Anna Taddio, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02174705    
Other Study ID Numbers: 30427
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Anna Taddio, University of Toronto:
vaccination
pain management
sucrose
rotavirus