Clinical trial NCT01780324
Conditions: Pediatric Presentation of Urinary Tract Infection
Sponsor: Seattle Children's Hospital
Start date: 2013-01-01; Completion date: 2015-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Aim

1\. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Secondary Aims

1. To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.

   To assess parental impression of discomfort between intervention and control groups.
3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.
4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Detailed description:
Purpose: To determine whether use of transurethral lidocaine prior to transurethral catheterization for sterile urine collection decreases procedural pain in children 0-3 years old. Primary Aim

1\. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Secondary Aims

1. To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.

   To assess parental impression of discomfort between intervention and control groups.
3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.
4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Rationale: Urinary tract infections (UTIs) are the leading cause of serious bacterial infection in young infants and children. Diagnosis of a UTI in patients in this age group generally requires obtaining a urine sample via transurethral bladder catheterization (TUBC). TUBC is painful, yet standard practice does not include analgesia for infants and children in need of this procedure.

Lidocaine is a commonly used topical anesthetic. Lidocaine jelly can be administered into the urethra prior to catheterization, typically via a preloaded syringe (eg,Uro-Jet) and is FDA approved for this indication. Lidocaine jelly has no antimicrobial characteristics and is a sterile preparation, such that it will not alter urine culture results.

This study is a randomized clinical trial to compare the effectiveness of local 2% lidocaine analgesia instilled in the urethra to reduce the pain and distress in children less than 3 years requiring TUBC.

Reducing the pain and distress associated with TUBC is an important treatment goal, yet there is limited research in children on the effect of intraurethral analgesia during TUBC.

There is growing evidence that children who receive inadequate pain control during invasive procedures may suffer long-term effects.

This Randomized Clinical Trial (RCT) could provide the evidence to drive a change in practice for infants and children requiring bladder catheterization, reducing pain and distress for children undergoing this procedure.

Study Design: This study will enroll 68 children over approximately 1 year. Inclusion criteria includes age 0-3 years, an English or Spanish speaking guardian present to provide consent, and a medical indication for TUBC during the patient's emergency department (ED) visit. Exclusion criteria includes severe developmental delay or impaired mentation; a neural tube defect, paraplegia, or other condition altering urethral sensation; a known urethral stricture, anatomic abnormality or reconstruction; a history of sexual abuse; patient weight less than 2.3 kg; allergy or previous adverse reaction to lidocaine; previous enrollment in the study; or prior successful or attempted TUBC in previous 7 days Subjects will be randomized to receive either usual care for TUBC or 2% lidocaine jelly administered intraurethrally approximately 5 minutes prior to TUBC. Group assignment will be block randomized and stratified by gender. In the lidocaine group, 2% lidocaine would be administered intraurethrally via a blunt tipped Uro-Jet® 5 minutes before TUBC. Lidocaine would not be administered to the usual care group. Both lidocaine administration (if applicable) and TUBC will be videotaped. Research team members will gather information on parental impression of discomfort and patient medical history as well as any adverse events.

A trained, blinded observer will review videotaped procedures and assign pain scores using the Faces, Legs, Activity, Cry and Consolability (FLACC) scale. The FLACC scale is a validated pain scale utilized in pre-verbal children, which assesses pain in 5 separate behaviors during a procedure. For TUBC, pain scores will be recorded at baseline, during catheterization, and one minute after. After assigning FLACC scores, the research team member will then review each video again and assign MBPS scores. MBPS pain scores will be recorded at baseline, during catheterization, and one minute after. Following scoring of the TUBC procedure, patients in the intervention study arm will also have FLACC pain scores assigned one minute before, during, and one minute after administration of lidocaine.

Arms: arm 1: This group will have urinary catheterization without lidocaine (per standard procedure) arm 2: The Intervention is the application of intraurethral lidocaine 5 minutes prior to urethral catheterization.
Interventions: intervention 1: Lidocaine
Intervention descriptions: intervention 1: Intervention - intraurethral lidocaine

Protocol documents: