Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01780324 |
| Other study ID # |
24080004 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 17, 2013 |
| Last updated |
May 19, 2015 |
| Start date |
January 2013 |
| Est. completion date |
May 2015 |
Study information
| Verified date |
May 2015 |
| Source |
Seattle Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Interventional
|
Clinical Trial 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.
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 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.
