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

NCT01690767 | Completed Phase 2

• 1 other identifier: 17770
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

Urethral catheterization; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Brow Bulging Score

  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.

  30 seconds post intervention compared to baseline

Secondary Outcomes (1)

• Facial grimacing score

  30 seconds post intervention compared to placebo

Study Arms (2)

Topical and intraurethral 2% lidocaine

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

According to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only. Intervention is Health Care Lubricating Jelly.

Drug: Health Care Lubricating Jelly

Interventions

2% lidocaine gel DRUG

Children \< 7 kg and \> 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively

Also known as: Lidocaine

Topical and intraurethral 2% lidocaine

Health Care Lubricating Jelly DRUG

Non-medicinal lubrication gel

Also known as: Muco

Standard of care

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen

You may not qualify if:

• unstable
• external genitourinary anomalies
• lidocaine allergy and
• previous catheterization within 24 hours

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital, London Health Sciences Center

London, Ontario, N6C 2V5, Canada

Location

Related Publications (1)

• 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.

  PMID: 26416942 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Naveen Poonai, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: September 24, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

CA (1)