Pain From ImmunizationNCT00954499
Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
A study of Pain From Immunization, run by Women's College Hospital at 1 site in Canada.
Trial summary
The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a… Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain From Immunization
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Nov 2010
- Phase
- Interventional
- 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 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants
- 4 to 6 months old
- routine immunization with DTaP-IPV-Hib and PCV
Who cannot join
- impaired neurological development
- history of seizure
- use of topical local anaesthetics at the injection site
- use of sedatives or narcotics in the preceding 24 hours
- fever or illness that would prevent administration of the vaccine
- parent is unable to use the assessment tools in the study
- parent does not speak English
- prior participation in this trial
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's College Hospital Family Practice Health Centre
Toronto, Ontario, M5S 1B6
About this study
The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions (least painful injection technique, holding by parent, and oral sucrose solution) and non-procedural talk by the parent, does the addition of rubbing near the site of injection reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than no rubbing?
Read the detailed description
Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain.
There are many non-pharmacological methods that can be used to reduce immunization pain. These include: sugar water, fast injection without aspiration, holding infants during the procedure, and non-procedural related parental behaviours such as distraction. At present, there are no studies of tactile stimulation during noxious procedures in infants and its effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that is administered by a parent immediately before, during and immediately after immunization is an easily learned, cost neutral intervention that could offer improved pain management.
- Conditions
- Pain From Immunization
- Being tested
- Tactile stimulation added to Standard care, Standard care
- Keywords
- tactile stimulation, pain, immunization, infant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulation added to Standard careBehavioural
- Parent rubs the infant's skin near the injection site just before, during and after the injection.
- Fast injection technique without aspiration.
- Oral sucrose 2 minutes before first injection.
- Parent holds infant close.
Standard careBehavioural
- Fast injection technique without aspiration.
- Oral sucrose 2 minutes before first injection.
- Parent holds infant close.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Not described Receives: Behavioral: Standard care |
| Tactile stimulation | Experimental | Not described Receives: Behavioral: Tactile stimulation added to Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).
Measured: at time of injection on day 1
Secondary outcomes (1)
Pain response to immunization as measured by observer Visual Analogue Scale (VAS).
Measured: at time of injection on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain From ImmunizationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anna Taddio, B.Sc.Phm, M.Sc., Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954499
- Sponsor's protocol ID
- 2009-0019
- Status last verified
- Feb 2011
- First submitted
- 22 Jul 2009
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
- ClinicalTrials.gov ID
- NCT00954499
- Acronym / sponsor ID
- 2009-0019
- Conditions
- Pain From Immunization
- Keywords
- tactile stimulation, pain, immunization, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Aug 2009 (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 answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions (least painful injection technique, holding by parent, and oral sucrose solution) and non-procedural talk by the parent, does the addition of rubbing near the site of injection reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than no rubbing?
Detailed description
Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain.
There are many non-pharmacological methods that can be used to reduce immunization pain. These include: sugar water, fast injection without aspiration, holding infants during the procedure, and non-procedural related parental behaviours such as distraction. At present, there are no studies of tactile stimulation during noxious procedures in infants and its effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that is administered by a parent immediately before, during and immediately after immunization is an easily learned, cost neutral intervention that could offer improved pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard care |
| Tactile stimulation | Experimental | Behavioral: Tactile stimulation added to Standard care |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy infants
- 4 to 6 months old
- routine immunization with DTaP-IPV-Hib and PCV
Key exclusion criteria (8 listed)
- impaired neurological development
- history of seizure
- use of topical local anaesthetics at the injection site
- use of sedatives or narcotics in the preceding 24 hours
- fever or illness that would prevent administration of the vaccine
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 |
|---|---|---|
| Tactile stimulation added to Standard care* Parent rubs the infant's skin near the injection site just before, during and after the injection. * Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close. | Behavioural | Tactile stimulation |
| Standard care* Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close. | Behavioural | Standard care |
Primary outcome
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).
Time frame: at time of injection on day 1
1 secondary outcome
Pain response to immunization as measured by observer Visual Analogue Scale (VAS).
Time frame: at time of injection on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
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, B.Sc.Phm, M.Sc., Ph.D. 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 study of Pain From Immunization, run by Women's College Hospital 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 1 Mar 2011. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS). (time frame: at time of injection on day 1). 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 1 Mar 2011.