A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01690767
First received: February 15, 2011
Last updated: September 21, 2012
Last verified: September 2012

February 15, 2011
September 21, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
Brow Bulging Score [ Time Frame: 30 seconds post intervention compared to baseline ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01690767 on ClinicalTrials.gov Archive Site
Facial grimacing score [ Time Frame: 30 seconds post intervention compared to placebo ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization
A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Urinary Tract Infection
  • Drug: 2% lidocaine gel
    Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively
    Other Name: Lidocaine
  • Drug: lubricant gel
  • Experimental: Topical and intraurethral 2% lidocaine
    2% lidocaine gel will be applied for 5 minutes to the external urethral opening. This will be followed immediately by 2% lidocaine gel administration into the urethra using a 24 gauge angiocath for 5 minutes prior to catheterization for urine specimen collection. Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc, respectively.
    Intervention: Drug: 2% lidocaine gel
  • Active Comparator: Standard of care
    According to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only
    Intervention: Drug: lubricant gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
January 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 24 Months
No
Contact: Cindy Langford 519 685 8500 ext 52011 cindy.langford@lhsc.on.ca
Canada
 
NCT01690767
17770
No
Naveen Poonai, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Naveen Poonai, MD, FRCPC University of Western Ontario, Canada
Lawson Health Research Institute
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP