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
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Drug: 2% lidocaine gel
Drug: lubricant gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 130
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Standard of care
According to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only
Drug: lubricant gel

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

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690767

Contacts
Contact: Cindy Langford 519 685 8500 ext 52011 cindy.langford@lhsc.on.ca

Locations
Canada, Ontario
Children's Hospital, London Health Sciences Center Recruiting
London, Ontario, Canada, N6C 2V5
Contact: Naveen P Poonai, MD    5196858500 ext 52011    naveen.poonai@lhsc.on.ca   
Principal Investigator: Naveen P Poonai, MD FRCPC         
Sub-Investigator: Rod Lim, MD FRCPC         
Sub-Investigator: Doreen Matsui, MD FRCPC         
Sub-Investigator: Jennifer Li, MD         
Sub-Investigator: Anna Taddio, MSc PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Naveen Poonai, MD, FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Naveen Poonai, Attending Physician, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01690767     History of Changes
Other Study ID Numbers: 17770
Study First Received: February 15, 2011
Last Updated: September 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Urethral catheterization
Lidocaine

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014