Urinary Tract Infection
Conditions
Keywords
Urethral catheterization, Lidocaine
Brief summary
Children 0-24 months of age requiring a urethral catheterization for urine collection will be randomized to receive either topical and intraurethral 2% lidocaine or standard of care to assess for the effectiveness of the former in minimizing pain during urethral catheterization. It is hypothesized that administration of 2% lidocaine gel both topically and intraurethrally will confer a greater degree of pain reduction compared to standard of care.
Detailed description
An estimated 10% of children 0-24 months of age that present to the emergency department (ED) with fever and/or vomiting have a urinary tract infection (UTI). An accurate diagnosis of a UTI ensures timely and appropriate treatment given to reduce the risk of renal scarring, which is the greatest in this age group. To ensure diagnostic accuracy, urethral catheterization is the preferred method to obtain a urine sample from a young child. In contrast to adults, most children do not receive local analgesia for urethral catheterization; despite growing recognition that children experience avoidable pain and discomfort during invasive procedures. Following informed consent, participants will be randomized by block randomization in a concealed fashion to receive either topical and intraurethral 2% lidocaine or standard of care using a computerized random number generator. The research nurse will access a sequentially numbered, opaque sealed envelope that will contain the participant's group assignment. No adjunctive analgesic methods will be used. A research pharmacist will prepare 2% lidocaine gel in a 3 cc syringe attached to a 24 gauge angiocath. Children \< 7 kg and \> 7 kg will receive 1 cc and 1.5 cc, respectively (2). The entire procedure will be videotaped and participants pain will be scored using a brow bulging score and visual analogue scale by independent, blinded raters.
Interventions
DRUG2% lidocaine gel
Children \< 7 kg and \> 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively
DRUGHealth Care Lubricating Jelly
Non-medicinal lubrication gel
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen
Exclusion criteria
* unstable * external genitourinary anomalies * lidocaine allergy and * previous catheterization within 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brow Bulging Score | 30 seconds post intervention compared to baseline | The presence of brow bulging will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that brow bulging is observed will then be calculated for each phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facial grimacing score | 30 seconds post intervention compared to placebo | The presence of brow bulging, nasolabial furrowing and eyes squeezing shut will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that all three of these features is observed will then be calculated for each phase. |
Countries
Canada
Outcome results
None listed