Comparison of Two Different Methods of Delivering Local Analgesia During Intra-articular Corticosteroid Injections in Children With Juvenile Idiopathic Arthritis
Condition: Pain
MeSH terms: Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

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 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:

        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).
    

Intervention name(s): iontophoresis
Intervention type(s): Procedure
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: local analgesia; intra-articular corticosteroid injection; iontophoresis; Local analgesia for intra-articular corticosteroid injection