Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465504
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2007-04-23
Brief Title:
Comparison of Two Different Methods of Delivering Local Analgesia During Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 childs 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
1 Children receiving analgesia with subcutaneous lidocaine 2 and EMLA cream Rheumatology Division standard of care arm n33
2 Children receiving analgesia with iontophoresis and EMLA cream experimental arm n33
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 Childrens 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 Students 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 ie tingling redness blanching itching blistering or pain Data collected will consist of the childs 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
1 Children receiving analgesia with subcutaneous lidocaine 2 and EMLA cream Rheumatology Division standard of care arm n33
2 Children receiving analgesia with iontophoresis and EMLA cream experimental arm n33
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 Childrens 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 Students 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 ie tingling redness blanching itching blistering or pain Data collected will consist of the childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None