PainNCT01224431
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
A study testing Buffered Lidocaine J-tip in people with Pain, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Pain
- What is being tested?
- Buffered Lidocaine J-tip
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- fever in infants less than 3 months
Who cannot join
- toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight
Trial locations and contacts
1 site in 1 country.
United States1 site
Blake Bulloch/PhoenixChildren's Hospital
Phoenix, Arizona, 85018
About this study
Official title: Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.
Read the detailed description
Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.
- Conditions
- Pain
- Being tested
- Buffered Lidocaine J-tip
- Keywords
- pain, lidocaine, lumbar puncture, j-tip
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered Lidocaine J-tipDrug
Also called Normal Saline J-tip
All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
| Study group | Role | What they receive |
|---|---|---|
| Buffered lidocaine J-tip | Experimental | Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) Receives: Drug: Buffered Lidocaine J-tip |
| Normal saline J-tip | Placebo comparator | Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine Receives: Drug: Buffered Lidocaine J-tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Measured as Units on a Scale
Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible
Measured: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
Secondary outcomes (1)
Length of Cry
cry video recorded and measured after needle stick until pt stopped crying
Measured: On average the first hour in the emergency department; from needle stick to end of lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blake Bulloch, Phoenix Children's Hospital
- Investigators
- Blake Bulloch, MD, Study director, Phoenix Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224431
- Sponsor's protocol ID
- 09-014
- Status last verified
- Sep 2018
- First submitted
- 30 Sep 2010
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.
PubMed 22743744
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01224431
- Acronym / sponsor ID
- 09-014
- Conditions
- Pain
- Keywords
- pain, lidocaine, lumbar puncture, j-tip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 14 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.
Detailed description
Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buffered lidocaine J-tip | Experimental | Drug: Buffered Lidocaine J-tipNeedleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) |
| Normal saline J-tip | Placebo comparator | Drug: Buffered Lidocaine J-tipNeedleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- fever in infants less than 3 months
Key exclusion criteria (1 listed)
- toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight
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 |
|---|---|---|
| Buffered Lidocaine J-tipAlso: Normal Saline J-tipAll patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded | Drug | Buffered lidocaine J-tip, Normal saline J-tip |
Primary outcome
Pain, Measured as Units on a Scale
Time frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible
1 secondary outcome
Length of Cry
Time frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22743744Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.
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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.
Blake Bulloch, MD study director
Phoenix Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffered Lidocaine J-tip in people with Pain, run by Phoenix Children's Hospital 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 1 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 23 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain, Measured as Units on a Scale (time frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.). 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 NCT01224431, 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 23 Oct 2018.