PainPhase 3NCT01006187
Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections
A Phase 3 study testing Liposomal lidocaine, Vapocoolant spray and Rubbing adjacent to the injection site in people with Pain and Anxiety, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Liposomal lidocaine, Vapocoolant spray and Rubbing adjacent to the injection site
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Nov 2009
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged >18 years of age undergoing voluntary immunization with influenza virus vaccine
Who cannot join
- Pre-medication with any of the analgesic interventions in this study,
- Chronic pain syndromes/conditions
- Receiving systemic analgesics and sedatives
- Abnormal circulation (e.g., Raynaud's phenomenon)
- Allergy/hypersensitivity to amide local anesthetics
- Allergy to influenza virus vaccine or constituents
Show all 9Show fewer
- Prior participation in the trial
- Inability to understand the VAS
- If suspected to be pregnant, pregnant or breastfeeding (due to possible treatment with liposomal lidocaine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization
Read the detailed description
In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e., topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults undergoing routine immunization in order to provide further evidence of the effectiveness of each intervention and to determine if one method is superior to another. We are not including a 'no treatment' group because we do not wish to subject participants to unnecessary pain when there are available analgesic treatments. Moreover, in the presence of a 'no treatment' group, we cannot rule out a placebo effect for all treatment groups unless we provide a matched placebo for each intervention, which is not feasible. In future studies, we plan to address the added benefit of combining analgesic interventions (i.e., evaluating the effect of a multimodal approach).
- Being tested
- Liposomal lidocaine, Vapocoolant spray, Rubbing adjacent to the injection site, Distraction
- Keywords
- Analgesics, Influenza, Vapocoolant, vaccination, pain
- Medical subject headings
- Pain, Anxiety Disorders, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal lidocaineDrug
Also called Maxilene™
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
Vapocoolant sprayDrug
Also called PainEase™
medium stream spray on arm for 4-10 seconds prior to injection
Rubbing adjacent to the injection siteOther
rubbing adjacent to the injection site before and during injection
DistractionOther
By means of self-selected reading material or video
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 1 liposomal lidocaine 4% cream . Receives: Drug: Liposomal lidocaine |
| Group 2 | Active comparator | Vapocoolant spray Receives: Drug: Vapocoolant spray |
| Group 3 | Active comparator | Rubbing adjacent to the injection site Receives: Other: Rubbing adjacent to the injection site |
| Group 4 | Active comparator | Distraction by means of self-selected reading material or internet Receives: Other: Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain from adult intramuscular influenza virus injection
Measured: 1 day
Secondary outcomes (2)
Adverse Events
Measured: 1 day
Anxiety
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Investigators
- Anna Taddio, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006187
- Sponsor's protocol ID
- 1000014280
- Status last verified
- Jul 2011
- First submitted
- 29 Oct 2009
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
PubMed 20483194
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
- ClinicalTrials.gov ID
- NCT01006187
- Acronym / sponsor ID
- 1000014280
- Keywords
- Analgesics, Influenza, Vapocoolant, vaccination, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Nov 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 purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization
Detailed description
In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e., topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults undergoing routine immunization in order to provide further evidence of the effectiveness of each intervention and to determine if one method is superior to another. We are not including a 'no treatment' group because we do not wish to subject participants to unnecessary pain when there are available analgesic treatments. Moreover, in the presence of a 'no treatment' group, we cannot rule out a placebo effect for all treatment groups unless we provide a matched placebo for each intervention, which is not feasible. In future studies, we plan to address the added benefit of combining analgesic interventions (i.e., evaluating the effect of a multimodal approach).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Liposomal lidocaine1 liposomal lidocaine 4% cream . |
| Group 2 | Active comparator | Drug: Vapocoolant sprayVapocoolant spray |
| Group 3 | Active comparator | Other: Rubbing adjacent to the injection siteRubbing adjacent to the injection site |
| Group 4 | Active comparator | Other: DistractionDistraction by means of self-selected reading material or internet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged >18 years of age undergoing voluntary immunization with influenza virus vaccine
Key exclusion criteria (9 listed)
- Pre-medication with any of the analgesic interventions in this study,
- Chronic pain syndromes/conditions
- Receiving systemic analgesics and sedatives
- Abnormal circulation (e.g., Raynaud's phenomenon)
- Allergy/hypersensitivity to amide local anesthetics
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 |
|---|---|---|
| Liposomal lidocaineAlso: Maxilene™4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection | Drug | Group 1 |
| Vapocoolant sprayAlso: PainEase™medium stream spray on arm for 4-10 seconds prior to injection | Drug | Group 2 |
| Rubbing adjacent to the injection siterubbing adjacent to the injection site before and during injection | Other | Group 3 |
| DistractionBy means of self-selected reading material or video | Other | Group 4 |
Primary outcome
Pain from adult intramuscular influenza virus injection
Time frame: 1 day
2 secondary outcomes
Adverse Events
Time frame: 1 day
Anxiety
Time frame: 1 hour
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 19 Jul 2011.
- Derived from this study: PubMed 20483194Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
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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
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 Liposomal lidocaine, Vapocoolant spray and Rubbing adjacent to the injection site in people with Pain and Anxiety, run by The Hospital for Sick Children 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 9 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 19 Jul 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.
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?
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 from adult intramuscular influenza virus injection (time frame: 1 day). 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 NCT01006187, 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 19 Jul 2011.