Seattle, Washington 98105

  • Need for Urethral Catheterization to Rule Out Urinary Tract Infection.

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Age 0-3 years - English or Spanish speaking - Legal guardian present to provide consent - Medical indication for TUBC during the patient's ED visit Exclusion Criteria: - Severe developmental delay or impaired mentation - Neural tube defect, paraplegia, or other condition altering urethral sensation - Known urethral stricture, anatomic abnormality or reconstruction - History of sexual abuse - Patient weight less than 2.3 kg - Allergy or previous adverse reaction to lidocaine - Previous enrollment in the study - Prior successful or attempted TUBC in previous 7 days


Study is Available At:


Original ID:

24080004


NCT ID:

NCT01780324


Secondary ID:


Study Acronym:


Brief Title:

Lidocaine Analgesia for Urethral Catheterization in Children


Official Title:

Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

3 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Seattle Children's Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Actual


Overall Contact Information

Official Name:Neil Uspal, MD
Principal Investigator
Seattle Children's

Study Dates

Start Date:January 2013
Completion Date:May 2015
Completion Type:Actual
Primary Completion Date:May 2014
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 19, 2015
First Received Date:January 17, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pain score on the FLACC scale
Time Frame:At time of procedure (up to 30 seconds after catheter insertion)
Safety Issues:False
Description:Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups

Study Interventions

Intervention Type:Drug
Name:Lidocaine gel
Arm Name:Lidocaine

Study Arms

Study Arm Type:Experimental
Arm Name:Lidocaine
Description:This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Study Arm Type:No Intervention
Arm Name:No lidocaine
Description:This group will have urinary catheterization without lidocaine (per standard procedure)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Seattle Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 05, 2021

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