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Comparison of Two Different Methods of Delivering Local Analgesia During Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465504
First Posted: April 25, 2007
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Columbia Childrens Hospital Foundation
Information provided by:
University of British Columbia
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 5
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: iontophoresis
    See Detailed Description.
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) (n=33)
  2. 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).

  Eligibility

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465504


Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
British Columbia Childrens Hospital Foundation
Investigators
Principal Investigator: Peter Malleson, MD University of British Columbia
  More Information

Responsible Party: Dr. Peter Malleson, University of British Columbia
ClinicalTrials.gov Identifier: NCT00465504     History of Changes
Other Study ID Numbers: H06-70290
First Submitted: April 23, 2007
First Posted: April 25, 2007
Last Update Posted: May 17, 2011
Last Verified: May 2011

Keywords provided by University of British Columbia:
local analgesia
intra-articular corticosteroid injection
iontophoresis
Local analgesia for intra-articular corticosteroid injection

Additional relevant MeSH terms:
Arthritis, Juvenile
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined