LeukemiaPhase 4NCT00808171
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
A Phase 4 study testing Livopan and EMLA in people with Leukemia and Non Hodgkin Lymphoma, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Non Hodgkin Lymphoma
- What is being tested?
- Livopan and EMLA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Aug 2011
- Phase
- Phase 4
- 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between four and 14 years;
- Not present cognitive disabilities;
- Necessity to perform the clinical procedure;
- Accordance in participating in the study.
Who cannot join
- Continuity skin lesion in the procedure site;
- Metahemoglobinemia;
- Neuromuscular disability;
- Presence of pneumothorax, emphysema, intra-abdominal infection, cranioencephalic traumatism, otitis media, sinusitis and intracranial hypertension;
- Vitamin B12 known deficits;
- Urgency for the procedure;
- Disagreement in participating of the project;
- Patients in use of Dapsone.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Pediatrics - Hematology section - Clinical Hospital of Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Official title: Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture
In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.
Read the detailed description
It is a randomized controlled clinical trial, double blinded, with the purpose to compare the use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50% in oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years old submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the Wong Baker faces scale and the visual numeric scale during six observational periods: baseline; three minutes after gas administration and before the first attempt of lumbar puncture; during the first lumbar puncture attempt; during the chemotherapy administration; during needle remove and three minutes after gas interruption. All the studied procedures will have clinical indication and will not be held by the researcher. The children was random divided within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group B (n=19)EMLA + gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.
Primary outcome was the detection of a difference of 20% or more in the visual numeric scale between the three treatment groups during the first attempt of lumbar puncture.
- Conditions
- Leukemia, Non Hodgkin Lymphoma
- Being tested
- Livopan, EMLA
- Keywords
- lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LivopanDrug
Also called equimolar mixture of nitrous oxide/oxygen
Inhalation of oxygen and nitrous oxide 50%
LivopanDrug
Also called equimolar mixture of nitrous oxide/oxygen
equimolar mixture of N2O/O2
EMLADrug
Also called Eutetic mixture of local anesthetics lidocaine/prilocaine
Lidocaine-prilocain cream
| Study group | Role | What they receive |
|---|---|---|
| EMLA and Livopan | Experimental | Administered EMLA and Livopan Receives: Drug: Livopan; Drug: EMLA |
| EMLA and gas placebo | Experimental | Administered EMLA and oxygen Receives: Drug: EMLA |
| Livopan and placebo cream | Experimental | Administered Livopan and placebo cream Receives: Drug: Livopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare analgesic efficacy of EMLA versus Nitrous oxide
Measured: Within first hour after the procedures
Secondary outcomes (1)
Evaluate analgesic synergism of EMLA versus nitrous oxide
Measured: One hour after the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionAug 2011
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 LeukemiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- Yerkes P Silva, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808171
- Sponsor's protocol ID
- CAAE0450020300008
- Status last verified
- Jul 2014
- First submitted
- 12 Dec 2008
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steedman B, Watson J, Ali S, Shields ML, Patmore RD, Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow examination. Clin Lab Haematol. 2006 Oct;28(5):321-4. doi: 10.1111/j.1365-2257.2006.00807.x.
PubMed 16999723
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture
- ClinicalTrials.gov ID
- NCT00808171
- Acronym / sponsor ID
- CAAE0450020300008
- Conditions
- Leukemia, Non Hodgkin Lymphoma
- Keywords
- lumbar punction, myelogram, pain assessment, nitrous oxide and EMLA, Leukemia and non Hodgkin lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Dec 2008 (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.
In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.
Detailed description
It is a randomized controlled clinical trial, double blinded, with the purpose to compare the use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50% in oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years old submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the Wong Baker faces scale and the visual numeric scale during six observational periods: baseline; three minutes after gas administration and before the first attempt of lumbar puncture; during the first lumbar puncture attempt; during the chemotherapy administration; during needle remove and three minutes after gas interruption. All the studied procedures will have clinical indication and will not be held by the researcher. The children was random divided within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group B (n=19)EMLA + gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.
Primary outcome was the detection of a difference of 20% or more in the visual numeric scale between the three treatment groups during the first attempt of lumbar puncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMLA and Livopan | Experimental | Drug: Livopan, Drug: EMLAAdministered EMLA and Livopan |
| EMLA and gas placebo | Experimental | Drug: EMLAAdministered EMLA and oxygen |
| Livopan and placebo cream | Experimental | Drug: LivopanAdministered Livopan and placebo cream |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between four and 14 years;
- Not present cognitive disabilities;
- Necessity to perform the clinical procedure;
- Accordance in participating in the study.
Key exclusion criteria (8 listed)
- Continuity skin lesion in the procedure site;
- Metahemoglobinemia;
- Neuromuscular disability;
- Presence of pneumothorax, emphysema, intra-abdominal infection, cranioencephalic traumatism, otitis media, sinusitis and intracranial hypertension;
- Vitamin B12 known deficits;
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 |
|---|---|---|
| LivopanAlso: equimolar mixture of nitrous oxide/oxygenInhalation of oxygen and nitrous oxide 50% | Drug | EMLA and Livopan |
| LivopanAlso: equimolar mixture of nitrous oxide/oxygenequimolar mixture of N2O/O2 | Drug | Livopan and placebo cream |
| EMLAAlso: Eutetic mixture of local anesthetics lidocaine/prilocaineLidocaine-prilocain cream | Drug | EMLA and Livopan, EMLA and gas placebo |
Primary outcome
Compare analgesic efficacy of EMLA versus Nitrous oxide
Time frame: Within first hour after the procedures
1 secondary outcome
Evaluate analgesic synergism of EMLA versus nitrous oxide
Time frame: One hour after the procedures
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 29 Jul 2014.
- Background: PubMed 16999723Steedman B, Watson J, Ali S, Shields ML, Patmore RD, Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow examination. Clin Lab Haematol. 2006 Oct;28(5):321-4. doi: 10.1111/j.1365-2257.2006.00807.x.
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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.
Yerkes P Silva, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Livopan and EMLA in people with Leukemia and Non Hodgkin Lymphoma, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 29 Jul 2014. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Compare analgesic efficacy of EMLA versus Nitrous oxide (time frame: Within first hour after the procedures). 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 NCT00808171, 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 29 Jul 2014.