A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization
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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: Health Care Lubricating Jelly |
Phase 2 |
| 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 |
- 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.
- 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: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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. Intervention is Health Care Lubricating Jelly.
|
Drug: Health Care Lubricating Jelly
Non-medicinal lubrication gel
Other Name: Muco
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01690767
| Contact: Cindy Langford | 519 685 8500 ext 52011 | cindy.langford@lhsc.on.ca |
| 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 | |
| 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 23, 2014 |
| 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 Anesthetics, Local Anti-Arrhythmia Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers |
ClinicalTrials.gov processed this record on March 03, 2015