Vaccination Pain ManagementPhase 3NCT02174705
Rotavirus vs. Sucrose for Vaccine Injection Pain
A Phase 3 study testing Sucrose and Rotavirus in people with Vaccination Pain Management, run by Anna Taddio at 2 sites in Canada.
Trial summary
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccination Pain Management
- What is being tested?
- Sucrose and Rotavirus
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life
Who cannot join
- impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Kindercare
Toronto, Ontario, M5N 1A8
Dan Flanders, MD, (416) 848-7665
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
- Not yet recruiting
Anna Taddio
Toronto, Ontario, M5S 3M2
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
Dan Flanders, MD
About this study
Official title: A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.
- Conditions
- Vaccination Pain Management
- Being tested
- Sucrose, Rotavirus
- Keywords
- vaccination, pain management, sucrose, rotavirus
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDrug
Sucrose 24% orally prior to vaccine injections
RotavirusDrug
Rotavirus vaccine orally prior to vaccine injections
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Sucrose prior to vaccine injections Receives: Drug: Sucrose |
| Rotavirus | Active comparator | Rotavirus prior to vaccine injections Receives: Drug: Rotavirus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall
Measured: immediately after vaccinations in 15 seconds
Secondary outcomes (3)
Distress
Observer rated cry duration after vaccination
Measured: immediately after vaccinations in 1 minute intervals for 2 minutes
Distress
Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)
Measured: immediately after vaccinations in 1 minute
Distress
Parent rated distress after each injection using a Numerical Rating Scale (0-10)
Measured: immediately after vaccinations in 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Taddio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174705
- Sponsor's protocol ID
- 30427
- Status last verified
- Aug 2014
- First submitted
- 22 Jun 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
- ClinicalTrials.gov ID
- NCT02174705
- Acronym / sponsor ID
- 30427
- Conditions
- Vaccination Pain Management
- Keywords
- vaccination, pain management, sucrose, rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anna TaddioUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Drug: SucroseSucrose prior to vaccine injections |
| Rotavirus | Active comparator | Drug: RotavirusRotavirus prior to vaccine injections |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life
Key exclusion criteria (1 listed)
- impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucroseSucrose 24% orally prior to vaccine injections | Drug | Sucrose |
| RotavirusRotavirus vaccine orally prior to vaccine injections | Drug | Rotavirus |
Primary outcome
Distress
Time frame: immediately after vaccinations in 15 seconds
Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall
3 secondary outcomes
Distress
Time frame: immediately after vaccinations in 1 minute intervals for 2 minutes
Distress
Time frame: immediately after vaccinations in 1 minute
Distress
Time frame: immediately after vaccinations in 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Taddio, PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sucrose and Rotavirus in people with Vaccination Pain Management, run by Anna Taddio at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-978-8822, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (time frame: immediately after vaccinations in 15 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.