Routine Infant ImmunizationsPhase 3NCT02504398
Speed of Injection and Pain During Routine Infant Vaccinations
A Phase 3 study testing Fast injection speed by immunizer and Slow injection speed by immunizer in people with Routine Infant Immunizations and Pain Management, run by University of Toronto at 1 site in Canada.
Trial summary
Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. Read more about this study
- Who is it for?
- Ages 2 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Routine Infant Immunizations, Pain Management
- What is being tested?
- Fast injection speed by immunizer and Slow injection speed by immunizer
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Aug 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 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 2 and 4 month old infants receiving their primary vaccine injections, PediacelTM (0.5mL) and PrevnarTM (0.5mL) (in conjunction with and preceded by oral RotarixTM vaccine) and healthy 6 month old infants receiving their routine vaccine injection, PediacelTM (0.5mL)
Who cannot join
- Infants with impaired neurological development; history of seizures; administration of sedatives or narcotics in the preceding 24 hours; parental inability to use study tools; parent vaccine refusal; prior participation in the trial; and refusal to be video recorded
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pediatric Consultants
Toronto, Ontario
Moshe M Ipp, MD, 416-924-1661, mm.ipp@utoronto.ca
Anna Taddio, PhD, 416-813-6235, anna.taddio@utoronto.ca
About this study
Official title: A Randomized Controlled Trial of Injection Technique for Infant Vaccination
Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.
Read the detailed description
To date, there has been no evidence-based guidance regarding the rate at which vaccines should be injected to minimize pain. This has led to a disparity in practice. Some vaccinators favour a slow rate of injection (around 8-10 sec/mL) while others prefer a more rapid rate of injection (around 2-4 sec/mL).The slow injection method leads to a longer needle dwelling time with the increased possibility of the needle moving around and causing pain by damaging muscle tissue. Rapid injection, on the other hand, may lead to a sudden distension of muscle tissue, which itself could be painful. Allowing the muscle sufficient time to distend in order to accommodate the vaccine might minimize pain. This study will address the identified knowledge gap by comparing pain in infants undergoing routine vaccinations with a fast vs. slow injection speed.
- Conditions
- Routine Infant Immunizations, Pain Management
- Being tested
- Fast injection speed by immunizer, Slow injection speed by immunizer
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast injection speed by immunizerOther
Slow injection speed by immunizerOther
| Study group | Role | What they receive |
|---|---|---|
| Fast injection | Experimental | Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer Receives: Other: Fast injection speed by immunizer |
| Slow injection | Active comparator | Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer Receives: Other: Slow injection speed by immunizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Behavioural Pain Score
Assessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure
Measured: up to 1 minute post-vaccinations
Secondary outcomes (2)
Infant Parent-rated Pain Score
Assessed using a Numerical Rating Scale (0-10) by parent in real time
Measured: up to 2 minutes
Infant Cry duration
Assessed in 1 minute intervals for 2 minutes following vaccinations from videotapes
Measured: up to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Routine Infant ImmunizationsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504398
- Sponsor's protocol ID
- 31803
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Wong H, Welkovics B, Ilersich AL, Cole M, Goldbach M, Ipp M. A randomized trial of the effect of vaccine injection speed on acute pain in infants. Vaccine. 2016 Sep 7;34(39):4672-4677. doi: 10.1016/j.vaccine.2016.08.023. Epub 2016 Aug 12.
PubMed 27527817
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Injection Technique for Infant Vaccination
- ClinicalTrials.gov ID
- NCT02504398
- Acronym / sponsor ID
- 31803
- Conditions
- Routine Infant Immunizations, Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 21 Jul 2015 (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.
Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.
Detailed description
To date, there has been no evidence-based guidance regarding the rate at which vaccines should be injected to minimize pain. This has led to a disparity in practice. Some vaccinators favour a slow rate of injection (around 8-10 sec/mL) while others prefer a more rapid rate of injection (around 2-4 sec/mL).The slow injection method leads to a longer needle dwelling time with the increased possibility of the needle moving around and causing pain by damaging muscle tissue. Rapid injection, on the other hand, may lead to a sudden distension of muscle tissue, which itself could be painful. Allowing the muscle sufficient time to distend in order to accommodate the vaccine might minimize pain. This study will address the identified knowledge gap by comparing pain in infants undergoing routine vaccinations with a fast vs. slow injection speed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast injection | Experimental | Other: Fast injection speed by immunizerVaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer |
| Slow injection | Active comparator | Other: Slow injection speed by immunizerVaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer |
Who may qualify
- Ages
- 2 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy 2 and 4 month old infants receiving their primary vaccine injections, PediacelTM (0.5mL) and PrevnarTM (0.5mL) (in conjunction with and preceded by oral RotarixTM vaccine) and healthy 6 month old infants receiving their routine vaccine injection, PediacelTM (0.5mL)
Key exclusion criteria (1 listed)
- Infants with impaired neurological development; history of seizures; administration of sedatives or narcotics in the preceding 24 hours; parental inability to use study tools; parent vaccine refusal; prior participation in the trial; and refusal to be video recorded
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 |
|---|---|---|
| Fast injection speed by immunizer | Other | Fast injection |
| Slow injection speed by immunizer | Other | Slow injection |
Primary outcome
Infant Behavioural Pain Score
Time frame: up to 1 minute post-vaccinations
Assessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure
2 secondary outcomes
Infant Parent-rated Pain Score
Time frame: up to 2 minutes
Infant Cry duration
Time frame: up to 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Derived from this study: PubMed 27527817Taddio A, Wong H, Welkovics B, Ilersich AL, Cole M, Goldbach M, Ipp M. A randomized trial of the effect of vaccine injection speed on acute pain in infants. Vaccine. 2016 Sep 7;34(39):4672-4677. doi: 10.1016/j.vaccine.2016.08.023. Epub 2016 Aug 12.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fast injection speed by immunizer and Slow injection speed by immunizer in people with Routine Infant Immunizations and Pain Management, run by University of Toronto at 1 site 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (416-813-6235, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Behavioural Pain Score (time frame: up to 1 minute post-vaccinations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504398, which also lists 1 linked publication.
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 23 Jul 2015.