PainPhase 3NCT00465504
Comparison of Two Different Methods of Delivering Local Analgesia During Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis
A Phase 3 study testing iontophoresis in people with Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Chronic arthritis (inflammation of joints) in children is known as Juvenile Idiopathic Arthritis (JIA). Often, to control the swelling and to help reduce the pain in the joint, medications (steroids) are injected into the joint. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- iontophoresis
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Dec 2007
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children aged >4 years with JIA and active arthritis of at least one knee despite treatment with NSAIDs or disease modifying anti-rheumatic drugs who are undergoing an IACI will be eligible.
Who cannot join
- Children who are allergic to lidocaine, any ingredient used in EMLA® cream or the iontophoresis pads
- Have electrically-sensitive support systems (i.e. pacemakers)
- Damaged skin or signs of infection at the injection site
- Suffering from a coagulation disorder
- Unable to evaluate pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Iontophoresis of Lidocaine and Eutectic Mixture of Local Anesthetics (EMLA®) Cream Versus Subcutaneous Injections of Lidocaine and EMLA® for Pain Relief in Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial
Chronic arthritis (inflammation of joints) in children is known as Juvenile Idiopathic Arthritis (JIA). Often, to control the swelling and to help reduce the pain in the joint, medications (steroids) are injected into the joint. These injections are sometimes painful, even if we use local anesthetics (lidocaine) to numb the skin; in fact, lidocaine injection is often the most painful part of the procedure. There is an alternate method called iontophoresis that uses an electric current to push lidocaine into the skin and deeper tissues avoiding the anesthetic injection. Very little work has been done to see if this is actually an effective way of numbing the skin in children having painful procedures such as joint injections. In this study, we will compare two groups of children with JIA having steroid injections into their joints: one group will get lidocaine by iontophoresis and the other will get it by the usual injection method. We will assess the child's pain during the steroid injection and compare the two groups to see if children who are given local anesthetic by iontophoresis experience less pain. The results of this study will provide new information about the effectiveness of the iontophoresis method, and whether or not this would be a better way to give local anesthetic for children undergoing other kinds of painful procedures.
Read the detailed description
Research method: This study will be a prospective, randomized clinical trial comparing two methods of delivery of local anesthesia for intra-articular corticosteroids injection (IACI) in children with JIA. There will be two study groups:
- Children receiving analgesia with subcutaneous lidocaine 2% and EMLA® cream (Rheumatology Division standard of care arm) (n=33)
- Children receiving analgesia with iontophoresis and EMLA® cream (experimental arm) (n=33).
About one child with JIA per week receives IACI in our institution. To minimize procedural variations in this study, we will select children undergoing knee (by far the most commonly injected joint) IACI by the Pediatric Rheumatology service at BC Children's Hospital. Randomization will be achieved with a Microsoft Access 2003 program. Our primary outcome measures will be change in pain between baseline pain assessed immediately prior to the corticosteroid injection, immediately after the local anesthetic application, and after the corticosteroid injection, using a 10-cm visual analogue scale (VAS, a continuous variable) and the Facial Pain Scale-Revised (FPS-R) scores (a categorical variable). The change in pain will be analyzed using Student's t-test for VAS scores and with Mann-Whitney U test for FPS-R scores. Descriptive statistics for demographic and auxiliary clinical variables will be presented in tables, including mean, range and standard deviation for continuous variables and median, range and percentiles for categorical variables.
Adverse events from EMLA® or iontophoresis will also be recorded (i.e. tingling, redness, blanching, itching, blistering, or pain). Data collected will consist of the child's age, gender, JIA type and duration, number and sites of previous IACIs, and other medications used and will have no patient identifiers (such as name, date of birth, personal health number).
- Conditions
- Pain
- Being tested
- iontophoresis
- Keywords
- local analgesia, intra-articular corticosteroid injection, iontophoresis, Local analgesia for intra-articular corticosteroid injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iontophoresisProcedure or surgery
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure will be the change in level of pain, from baseline pain at maximal range of motion (ROM) to pain associated with the procedure, as rated by the child and parent. This approach contrasts with measurement of absolute levels of pain
Secondary outcomes (1)
Secondary outcomes will include pain scores during the procedure as follows: 1 during the application of the analgesic agents and 2. at a 24 hours follow-up telephone call. Will be attained by July 2008.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Childrens Hospital Foundation
- Investigators
- Peter Malleson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465504
- Sponsor's protocol ID
- H06-70290
- Status last verified
- May 2011
- First submitted
- 23 Apr 2007
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Iontophoresis of Lidocaine and Eutectic Mixture of Local Anesthetics (EMLA®) Cream Versus Subcutaneous Injections of Lidocaine and EMLA® for Pain Relief in Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00465504
- Acronym / sponsor ID
- H06-70290
- Conditions
- Pain
- Keywords
- local analgesia, intra-articular corticosteroid injection, iontophoresis, Local analgesia for intra-articular corticosteroid injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Childrens Hospital Foundation
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Apr 2007 (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.
Chronic arthritis (inflammation of joints) in children is known as Juvenile Idiopathic Arthritis (JIA). Often, to control the swelling and to help reduce the pain in the joint, medications (steroids) are injected into the joint. These injections are sometimes painful, even if we use local anesthetics (lidocaine) to numb the skin; in fact, lidocaine injection is often the most painful part of the procedure. There is an alternate method called iontophoresis that uses an electric current to push lidocaine into the skin and deeper tissues avoiding the anesthetic injection. Very little work has been done to see if this is actually an effective way of numbing the skin in children having painful procedures such as joint injections. In this study, we will compare two groups of children with JIA having steroid injections into their joints: one group will get lidocaine by iontophoresis and the other will get it by the usual injection method. We will assess the child's pain during the steroid injection and compare the two groups to see if children who are given local anesthetic by iontophoresis experience less pain. The results of this study will provide new information about the effectiveness of the iontophoresis method, and whether or not this would be a better way to give local anesthetic for children undergoing other kinds of painful procedures.
Detailed description
Research method: This study will be a prospective, randomized clinical trial comparing two methods of delivery of local anesthesia for intra-articular corticosteroids injection (IACI) in children with JIA. There will be two study groups:
- Children receiving analgesia with subcutaneous lidocaine 2% and EMLA® cream (Rheumatology Division standard of care arm) (n=33)
- Children receiving analgesia with iontophoresis and EMLA® cream (experimental arm) (n=33).
About one child with JIA per week receives IACI in our institution. To minimize procedural variations in this study, we will select children undergoing knee (by far the most commonly injected joint) IACI by the Pediatric Rheumatology service at BC Children's Hospital. Randomization will be achieved with a Microsoft Access 2003 program. Our primary outcome measures will be change in pain between baseline pain assessed immediately prior to the corticosteroid injection, immediately after the local anesthetic application, and after the corticosteroid injection, using a 10-cm visual analogue scale (VAS, a continuous variable) and the Facial Pain Scale-Revised (FPS-R) scores (a categorical variable). The change in pain will be analyzed using Student's t-test for VAS scores and with Mann-Whitney U test for FPS-R scores. Descriptive statistics for demographic and auxiliary clinical variables will be presented in tables, including mean, range and standard deviation for continuous variables and median, range and percentiles for categorical variables.
Adverse events from EMLA® or iontophoresis will also be recorded (i.e. tingling, redness, blanching, itching, blistering, or pain). Data collected will consist of the child's age, gender, JIA type and duration, number and sites of previous IACIs, and other medications used and will have no patient identifiers (such as name, date of birth, personal health number).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children aged >4 years with JIA and active arthritis of at least one knee despite treatment with NSAIDs or disease modifying anti-rheumatic drugs who are undergoing an IACI will be eligible.
Key exclusion criteria (5 listed)
- Children who are allergic to lidocaine, any ingredient used in EMLA® cream or the iontophoresis pads
- Have electrically-sensitive support systems (i.e. pacemakers)
- Damaged skin or signs of infection at the injection site
- Suffering from a coagulation disorder
- Unable to evaluate pain
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 |
|---|---|---|
| iontophoresisSee Detailed Description. | Procedure or surgery | – |
Primary outcome
The main outcome measure will be the change in level of pain, from baseline pain at maximal range of motion (ROM) to pain associated with the procedure, as rated by the child and parent. This approach contrasts with measurement of absolute levels of pain
1 secondary outcome
Secondary outcomes will include pain scores during the procedure as follows: 1 during the application of the analgesic agents and 2. at a 24 hours follow-up telephone call. Will be attained by July 2008.
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 17 May 2011.
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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.
Peter Malleson, MD principal investigator
University of British Columbia
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 iontophoresis in people with Pain, run by University of British Columbia 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 5 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 17 May 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?
The main outcome measure will be the change in level of pain, from baseline pain at maximal range of motion (ROM) to pain associated with the procedure, as rated by the child and parent. This approach contrasts with measurement of absolute levels of pain. 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 17 May 2011.