Urinary Tract InfectionPhase 2NCT01690767
A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization
A Phase 2 study testing 2% lidocaine gel and Health Care Lubricating Jelly in people with Urinary Tract Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- 2% lidocaine gel and Health Care Lubricating Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen
Who cannot join
- unstable
- external genitourinary anomalies
- lidocaine allergy and
- previous catheterization within 24 hours
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital, London Health Sciences Center
London, Ontario, N6C 2V5
About this study
Official title: A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization
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.
Read the 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
- Being tested
- 2% lidocaine gel, Health Care Lubricating Jelly
- Keywords
- Urethral catheterization, Lidocaine
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaine gelDrug
Also called Lidocaine
Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively
Health Care Lubricating JellyDrug
Also called Muco
Non-medicinal lubrication gel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Health Care Lubricating Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 seconds post intervention compared to baseline
Secondary outcomes (1)
Facial grimacing score
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.
Measured: 30 seconds post intervention compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Poonai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Naveen Poonai, MD, FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690767
- Sponsor's protocol ID
- 17770
- Status last verified
- Mar 2015
- First submitted
- 15 Feb 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26416942
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization
- ClinicalTrials.gov ID
- NCT01690767
- Acronym / sponsor ID
- 17770
- Conditions
- Urinary Tract Infection
- Keywords
- Urethral catheterization, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical and intraurethral 2% lidocaine | Experimental | Drug: 2% lidocaine gel2% 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. |
| Standard of care | Active comparator | Drug: Health Care Lubricating JellyAccording to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only. Intervention is Health Care Lubricating Jelly. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen
Key exclusion criteria (4 listed)
- unstable
- external genitourinary anomalies
- lidocaine allergy and
- previous catheterization within 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% lidocaine gelAlso: LidocaineChildren < 7 kg and > 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively | Drug | Topical and intraurethral 2% lidocaine |
| Health Care Lubricating JellyAlso: MucoNon-medicinal lubrication gel | Drug | Standard of care |
Primary outcome
Brow Bulging Score
Time frame: 30 seconds post intervention compared to baseline
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.
1 secondary outcome
Facial grimacing score
Time frame: 30 seconds post intervention compared to placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Derived from this study: PubMed 26416942Poonai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Poonai, MD, FRCPC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2% lidocaine gel and Health Care Lubricating Jelly in people with Urinary Tract Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brow Bulging Score (time frame: 30 seconds post intervention compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.