Spinal Puncture ComplicationsOLPICNCT02454894
Optimization Lumbar Puncture In Children
A study testing lidocaine and postoperative management in people with Spinal Puncture Complications, run by Beijing Children's Hospital.
Trial summary
The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Spinal Puncture Complications
- What is being tested?
- lidocaine and postoperative management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Mar 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
About this study
The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation 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),less postoperative complications and comfortable LP will be anticipated.
- Conditions
- Spinal Puncture Complications
- Being tested
- lidocaine, postoperative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
surface anesthesia with lidocaine
postoperative managementProcedure or surgery
lying without the pillow for half an hour after lumbar puncture
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | no anesthesia; postoperative management Receives: Procedure: postoperative management |
| Group 2 | No intervention | no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture |
| Group 3 | Experimental | surface anesthesia with lidocaine; postoperative management Receives: Drug: lidocaine; Procedure: postoperative management |
| Group 4 | Experimental | surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy
Measured: up to five days postoperation
Secondary outcomes (7)
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.
Measured: up to four hours postoperation
degree of adaptability
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
Measured: intraoperative
time of lumbar puncture
Measured: intraoperative
number of puncture
Measured: intraoperative
success rate
Measured: intraoperative
comfort degree
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
Measured: up to four hours postoperation
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 posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Due to the reason that not all participants agree to have anesthesia and postoperative management at the same time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Puncture ComplicationsStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT02454894
- Sponsor's protocol ID
- 20150206
- Acronym
- OLPIC
- Status last verified
- May 2015
- First submitted
- 13 Mar 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
- Optimization Lumbar Puncture In Children
- ClinicalTrials.gov ID
- NCT02454894
- Acronym / sponsor ID
- OLPIC / 20150206
- Conditions
- Spinal Puncture Complications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the reason that not all participants agree to have anesthesia and postoperative management at the same time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 May 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 prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation 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),less postoperative complications and comfortable LP will be anticipated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: postoperative managementno anesthesia; postoperative management |
| Group 2 | No intervention | –no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture |
| Group 3 | Experimental | Drug: lidocaine, Procedure: postoperative managementsurface anesthesia with lidocaine; postoperative management |
| Group 4 | Experimental | Drug: lidocainesurface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture |
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 3, Group 4 |
| postoperative managementlying without the pillow for half an hour after lumbar puncture | Procedure or surgery | Group 1, Group 3 |
Primary outcome
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy
Time frame: up to five days postoperation
7 secondary outcomes
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.
Time frame: up to four hours postoperation
degree of adaptability
Time frame: intraoperative
time of lumbar puncture
Time frame: intraoperative
number of puncture
Time frame: intraoperative
success rate
Time frame: intraoperative
comfort degree
Time frame: up to four hours postoperation
whether bad memories exist or not
Time frame: up to four hours postoperation
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 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.
Gang Liu, MD principal investigator
Beijing Childrens' Hospital
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine and postoperative management in people with Spinal Puncture Complications, 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: withdrawn, 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?
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?
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy (time frame: up to five days postoperation). 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.