Clinical trial NCT01690767: A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization
Official title: A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infection
Keywords: Urethral catheterization
Lidocaine
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 133
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brow Bulging Score
timeFrame: 30 seconds post intervention compared to baseline
Secondary outcomes:
measure: Facial grimacing score
timeFrame: 30 seconds post intervention compared to placebo
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Center
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Naveen Poonai, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poonai N, Li J, Langford C, Lepore N, Taddio A, Gerges S, Stitt L, Teefy J, Manji K, Castelo M, Rieder M, Qui T, Matsui D, Ali S. Intraurethral Lidocaine for Urethral Catheterization in Children: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):e879-86. doi: 10.1542/peds.2015-1852.