PainEarly Phase 1NCT00924963
J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
A Early Phase 1 study testing J-Tip jet injector, Jet injection saline and lidocaine cream in people with Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or… Read more about this study
- Who is it for?
- Ages 7 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- J-Tip jet injector, Jet injection saline and lidocaine cream
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Early Phase 1
- 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 7 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged seven to twenty-one years old requiring venipuncture or PIVC insertion as part of their emergency department care are eligible for the study.
Who cannot join
- Lidocaine allergy,
- TegadermTM allergy,
- Glasgow Coma Score (GCS) less than 15,
- Pain at the proposed site for the procedure,
- Requirement of a PIVC or venipuncture immediately due to illness acuity,
- Inability to complete a self-reported pain scale (VAS, visual analogue scale),
- Patients who do not speak and understand English, OR
- Previous enrollment in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Liberty Township Emergency Department
Liberty Township, Ohio, 45044
About this study
Official title: Comparison of J-Tip® Jet Injection of 1% Buffered Lidocaine, 4% Lidocaine Topical Cream, and J-Tip® Jet Injection of Placebo Prior to Venipuncture and Peripheral Intravenous Catheter Insertion in a Pediatric Emergency Department
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.
Read the detailed description
Background: Venipuncture and PIVC insertion are the most common procedures performed in the pediatric emergency department. They are painful procedures, and frequently no local anesthesia is provided. The American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine has recommended that local anesthesia be provided, but a variety of barriers exist which have prevented implementation of this recommendation.
Specific Aims: To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream.
Methods: This study is a partially blinded, placebo controlled, randomized controlled clinical trial in the pediatric emergency department. The comparison of J-Tip® jet injection of 1% buffered lidocaine to J-Tip® jet injection of sterile saline is double blinded, while the comparison of jet injection to 4% lidocaine topical cream is not blinded. Forty-four patients per group will be enrolled, and a VAS self-reported measurement will be recorded for the pain of venipuncture or PIVC insertion following the appropriate treatment. As well, success of the procedure and complications of treatment will be recorded.
Results: Pain scores will be analyzed by pairwise comparisons using a t-test and pooled comparisons using ANOVA. Demographics will be assessed to determine baseline differences among the three groups. Chi square and regression analysis will be performed on demographic differences to determine significance if necessary. Final pain results will be reported as mean, standard deviation, and p-value. Demographics will be reported as number, percent of patients, and p-value (if a difference exists).
- Conditions
- Pain
- Being tested
- J-Tip jet injector, Jet injection saline, lidocaine cream
- Keywords
- Pain of venipuncture or IV insertion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-Tip jet injectorDevice
Also called J-Tip jet injector with 1% buffered lidocaine
0.2ml 1%buffered lidocaine delivered by jet injector
Jet injection salineDevice
Also called J-Tip Jet injection with saline
0.2ml saline delivered via J-Tip jet injection
lidocaine creamDrug
Also called 4% lidocaine cream
4% lidocaine cream applied for 30 minutes to the skin
| Study group | Role | What they receive |
|---|---|---|
| Jet injection lidocaine | Experimental | J-Tip jet injection of 1% buffered lidocaine Receives: Device: J-Tip jet injector |
| Jet injection saline | Placebo comparator | J-Tip jet injection of sterile saline Receives: Device: Jet injection saline |
| Lidocaine cream | Active comparator | Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture Receives: Drug: lidocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion
- Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus 4% lidocaine topical cream
Measured: 30 minutes
Secondary outcomes (5)
Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies
Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus jet injection of sterile saline
Measured: 30 minutes
Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores
compare pain scores across groups if a second attempt was made using VAS scores
Measured: 30 minutes
The success of venipuncture or PIVC insertion with all anesthetic techniques
Compare all types of anesthetics during venipuncture or PIVC
Measured: 30 minutes
Variety of locations of successful venipuncture or PIVC insertion after jet injection use
compare successful venipunctures across locations
Measured: 30 minutes
Measurement of complication rate after jet injection use
Compare variability of complications that arise post injection across groups
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Study ended due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie L Spanos, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiSrikant Iyer, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924963
- Sponsor's protocol ID
- 2008-0922
- Status last verified
- Sep 2020
- First submitted
- 18 Jun 2009
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of J-Tip® Jet Injection of 1% Buffered Lidocaine, 4% Lidocaine Topical Cream, and J-Tip® Jet Injection of Placebo Prior to Venipuncture and Peripheral Intravenous Catheter Insertion in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00924963
- Acronym / sponsor ID
- 2008-0922
- Conditions
- Pain
- Keywords
- Pain of venipuncture or IV insertion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study ended due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Jun 2009 (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.
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.
Detailed description
Background: Venipuncture and PIVC insertion are the most common procedures performed in the pediatric emergency department. They are painful procedures, and frequently no local anesthesia is provided. The American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine has recommended that local anesthesia be provided, but a variety of barriers exist which have prevented implementation of this recommendation.
Specific Aims: To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream.
Methods: This study is a partially blinded, placebo controlled, randomized controlled clinical trial in the pediatric emergency department. The comparison of J-Tip® jet injection of 1% buffered lidocaine to J-Tip® jet injection of sterile saline is double blinded, while the comparison of jet injection to 4% lidocaine topical cream is not blinded. Forty-four patients per group will be enrolled, and a VAS self-reported measurement will be recorded for the pain of venipuncture or PIVC insertion following the appropriate treatment. As well, success of the procedure and complications of treatment will be recorded.
Results: Pain scores will be analyzed by pairwise comparisons using a t-test and pooled comparisons using ANOVA. Demographics will be assessed to determine baseline differences among the three groups. Chi square and regression analysis will be performed on demographic differences to determine significance if necessary. Final pain results will be reported as mean, standard deviation, and p-value. Demographics will be reported as number, percent of patients, and p-value (if a difference exists).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jet injection lidocaine | Experimental | Device: J-Tip jet injectorJ-Tip jet injection of 1% buffered lidocaine |
| Jet injection saline | Placebo comparator | Device: Jet injection salineJ-Tip jet injection of sterile saline |
| Lidocaine cream | Active comparator | Drug: lidocaine creamLidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children aged seven to twenty-one years old requiring venipuncture or PIVC insertion as part of their emergency department care are eligible for the study.
Key exclusion criteria (8 listed)
- Lidocaine allergy,
- TegadermTM allergy,
- Glasgow Coma Score (GCS) less than 15,
- Pain at the proposed site for the procedure,
- Requirement of a PIVC or venipuncture immediately due to illness acuity,
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 |
|---|---|---|
| J-Tip jet injectorAlso: J-Tip jet injector with 1% buffered lidocaine0.2ml 1%buffered lidocaine delivered by jet injector | Device | Jet injection lidocaine |
| Jet injection salineAlso: J-Tip Jet injection with saline0.2ml saline delivered via J-Tip jet injection | Device | Jet injection saline |
| lidocaine creamAlso: 4% lidocaine cream4% lidocaine cream applied for 30 minutes to the skin | Drug | Lidocaine cream |
Primary outcome
Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion
Time frame: 30 minutes
1. Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus 4% lidocaine topical cream
5 secondary outcomes
Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies
Time frame: 30 minutes
Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores
Time frame: 30 minutes
The success of venipuncture or PIVC insertion with all anesthetic techniques
Time frame: 30 minutes
Variety of locations of successful venipuncture or PIVC insertion after jet injection use
Time frame: 30 minutes
Measurement of complication rate after jet injection use
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
Stephanie L Spanos, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Srikant Iyer, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing J-Tip jet injector, Jet injection saline and lidocaine cream in people with Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 21 Sep 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2020.