Spinal PunctureALPICNCT02590705
Anesthesia Lumbar Puncture In Children
A study testing Lidocaine in people with Spinal Puncture and Anesthesia, run by Beijing Children's Hospital.
Trial summary
The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Spinal Puncture, Anesthesia
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with indications of lumbar puncture;
- voluntarily signed the informed consent
Who cannot join
- topical anesthetic skin allergies;
- skin infection in lumbar puncture site;
- severe intracranial hypertension;
- unstable vital signs;
- coagulopathy;
- intracranial hemorrhage and occupying;
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- low back pain;
- headache and low back pain before lumbar puncture;
- past headache after lumbar puncture;
- mental retardation, neuropsychiatric symptoms;
- children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);
- the case with repeated puncture in one operation
Trial locations and contacts
No sites are listed yet.
Bing Hu, postgraduate contact
Bing Liu, postgraduate contact
About this study
Official title: Anesthesia Lumbar Puncture In Children (ALPIC)
The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
Read the detailed description
The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.
- Conditions
- Spinal Puncture, Anesthesia
- Being tested
- Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
surface anesthesia with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | surface anesthesia with lidocaine Receives: Drug: Lidocaine |
| Group 2 | No intervention | no anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of adaptability
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
Measured: intraoperative
Secondary outcomes (4)
time of lumbar puncture
Measured: intraoperative
number of puncture
Measured: intraoperative
success rate
Measured: intraoperative
whether bad memories exist or not
A questionaire about the operation for all parents and children will be investigated.
Measured: up to four hours postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal PunctureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Liu, Beijing Children's Hospital
- Investigators
- Gang Liu, MD, Principal investigator, Beijing Childrens' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590705
- Sponsor's protocol ID
- 20150825
- Acronym
- ALPIC
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Lumbar Puncture In Children (ALPIC)
- ClinicalTrials.gov ID
- NCT02590705
- Acronym / sponsor ID
- ALPIC / 20150825
- Conditions
- Spinal Puncture, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 29 Oct 2015 (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.
The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
Detailed description
The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Lidocainesurface anesthesia with lidocaine |
| Group 2 | No intervention | –no anesthesia |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children with indications of lumbar puncture;
- voluntarily signed the informed consent
Key exclusion criteria (12 listed)
- topical anesthetic skin allergies;
- skin infection in lumbar puncture site;
- severe intracranial hypertension;
- unstable vital signs;
- coagulopathy;
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 |
|---|---|---|
| Lidocainesurface anesthesia with lidocaine | Drug | Group 1 |
Primary outcome
degree of adaptability
Time frame: intraoperative
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
4 secondary outcomes
time of lumbar puncture
Time frame: intraoperative
number of puncture
Time frame: intraoperative
success rate
Time frame: intraoperative
whether bad memories exist or not
Time frame: up to four hours postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
Bing Hu, postgraduate contact
Bing Liu, postgraduate contact
Gang Liu, MD principal investigator
Beijing Childrens' Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Spinal Puncture and Anesthesia, run by Beijing Children's Hospital.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Hu, postgraduate (hubing6028@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of adaptability (time frame: intraoperative). 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 29 Oct 2015.