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

NCT ID: NCT01690767

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

2% lidocaine gel

Intervention Type: DRUG

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

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Health Care Lubricating Jelly

Intervention Type: DRUG

Non-medicinal lubrication gel

Interventions

2% lidocaine gel

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

Intervention Type: DRUG

Health Care Lubricating Jelly

Non-medicinal lubrication gel

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Muco

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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Naveen Poonai

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naveen Poonai, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

Children's Hospital, London Health Sciences Center

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26416942 (View on PubMed)

Other Identifiers

17770

Identifier Type: -

Identifier Source: org_study_id