PainPhase 3NCT01503060
Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
A Phase 3 study testing Educational video - Active and Sucrose in people with Pain, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants. Read more about this study
- Who is it for?
- Ages 2 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Educational video - Active and Sucrose
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2011to Apr 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 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Healthy infants undergoing vaccination.
Who cannot join
- preterm birth (<37 weeks gestation)
- prior hospitalization/surgery (other than postnatal care),
- documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
- mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Outpatient Clinic
Toronto, Ontario, M4V 2S2
Moshe Ipp, MD, (416) 924-7171, moshe.ipp@sickkids.ca
Moshe Ipp, MD
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5V1X8
Anna Taddio, PhD
Anna Taddio, PhD
About this study
Official title: Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.
- Conditions
- Pain
- Being tested
- Educational video - Active, Educational Video - Sham, Sucrose Placebo (water), Sucrose, Lidocaine Placebo
- Keywords
- pediatrics, Pain, Immunization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational video - ActiveBehavioural
The active video will instruct parents in techniques related to optimal infant soothing.
Educational Video - ShamBehavioural
The sham video will provide general information about immunization immunization pain management.
Sucrose Placebo (water)Drug
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
SucroseDrug
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
Lidocaine PlaceboDrug
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
LidocaineDrug
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | * Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Receives: Behavioral: Educational Video - Sham; Drug: Sucrose Placebo (water); Drug: Lidocaine Placebo |
| Group 2 | Active comparator | * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Receives: Behavioral: Educational video - Active; Drug: Sucrose Placebo (water); Drug: Lidocaine Placebo |
| Group 3 | Active comparator | * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Receives: Behavioral: Educational video - Active; Drug: Sucrose; Drug: Lidocaine Placebo |
| Group 4 | Active comparator | * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic
* Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Receives: Behavioral: Educational video - Active; Drug: Sucrose; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity to pain
This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months
Measured: At 15 month vaccination (Visit 5)
Secondary outcomes (1)
Effectiveness of interventions
This will be assessed by comparing the pain scores between groups
Measured: At 2,4,6,12 month vaccinations (Visit 1-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Taddio, The Hospital for Sick Children
- Investigators
- Anna Taddio, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503060
- Sponsor's protocol ID
- 1000025726
- Status last verified
- Nov 2015
- First submitted
- 29 Dec 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
PubMed 28455250Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.
PubMed 27956393
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01503060
- Acronym / sponsor ID
- 1000025726
- Conditions
- Pain
- Keywords
- pediatrics, Pain, Immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2016 (estimated)
- First posted
- 2 Jan 2012 (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.
The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Behavioral: Educational Video - Sham, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo* Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. |
| Group 2 | Active comparator | Behavioral: Educational video - Active, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. |
| Group 3 | Active comparator | Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine Placebo* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. |
| Group 4 | Active comparator | Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine* Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. |
Who may qualify
- Ages
- 2 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Healthy infants undergoing vaccination.
Key exclusion criteria (4 listed)
- preterm birth (<37 weeks gestation)
- prior hospitalization/surgery (other than postnatal care),
- documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
- mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
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 |
|---|---|---|
| Educational video - ActiveThe active video will instruct parents in techniques related to optimal infant soothing. | Behavioural | Group 2, Group 3, Group 4 |
| Educational Video - ShamThe sham video will provide general information about immunization immunization pain management. | Behavioural | Group 1 |
| Sucrose Placebo (water)Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination | Drug | Group 1, Group 2 |
| SucroseInfants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination | Drug | Group 3, Group 4 |
| Lidocaine PlaceboInfants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination | Drug | Group 1, Group 2, Group 3 |
| LidocaineInfants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination | Drug | Group 4 |
Primary outcome
Hypersensitivity to pain
Time frame: At 15 month vaccination (Visit 5)
This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months
1 secondary outcome
Effectiveness of interventions
Time frame: At 2,4,6,12 month vaccinations (Visit 1-4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Derived from this study: PubMed 28455250Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
- Derived from this study: PubMed 27956393Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 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
The Hospital for Sick Children
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 Educational video - Active and Sucrose in people with Pain, run by The Hospital for Sick Children 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 4 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 10 Nov 2015. 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. Some participants in this study may receive a placebo. 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@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersensitivity to pain (time frame: At 15 month vaccination (Visit 5)). 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 NCT01503060, which also lists 2 linked publications.
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 10 Nov 2015.