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

NCT00465504 | Completed Phase 3

• 1 other identifier: H06-70290
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain

Keywords

local analgesia; intra-articular corticosteroid injection; iontophoresis; Local analgesia for intra-articular corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

iontophoresis PROCEDURE

See Detailed Description.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Childrens Hospital Foundation: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Peter Malleson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: July 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

CA (1)