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

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.

Timeline

Start

2011-12

Primary completion

2014-12

Completion

2014-12

Outcome

Missed primary endpoint

paper scores during UC between lidocaine and NAL (86.4% [121.5%] vs 85.2% [126.6%]), respectively (Δ [confidence interval (CI)] = -1.2 [-21.0 to 49.0], P = .4). PMID 26416942 ↗

paper topical and intraurethral lidocaine is not associated with significant pain reduction during UC PMID 26416942 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	1 ml	Topical
Subject	Lidocaine	Other / unclassified	1.5 ml	Topical

Indications