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| Sponsor: | University of British Columbia |
|---|---|
| Collaborator: |
British Columbia Childrens Hospital Foundation |
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00465504 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Procedure: iontophoresis |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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 |
| Estimated Enrollment: | 66 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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:
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).
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: America Uribe, Ph.D | 604-875-2000 ext 5091 | auribe@cw.bc.ca |
| Canada, British Columbia | |
| BC Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: America Uribe, Ph.D 604-875-2000 ext 5091 auribe@cw.bc.ca | |
| Principal Investigator: | Peter Malleson, MD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Peter Malleson ) |
| Study ID Numbers: | H06-70290 |
| Study First Received: | April 23, 2007 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00465504 History of Changes |
| Health Authority: | Canada: Health Canada |
|
local analgesia intra-articular corticosteroid injection iontophoresis Local analgesia for intra-articular corticosteroid injection |
|
EMLA Arthritis, Juvenile Rheumatoid Autoimmune Diseases Immune System Diseases Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Anesthetics Central Nervous System Depressants Rheumatic Diseases |
Anesthetics, Local Pharmacologic Actions Musculoskeletal Diseases Anesthetics, Combined Sensory System Agents Therapeutic Uses Arthritis Connective Tissue Diseases Peripheral Nervous System Agents Central Nervous System Agents |