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

Lawson Health Research Institute

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Infection

Treatments: Drug: Health Care Lubricating Jelly; Drug: 2% lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01690767

17770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups

Topical and intraurethral 2% lidocaine

Experimental group

Description:

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.

Treatment:

Drug: 2% lidocaine gel

Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Health Care Lubricating Jelly