BurnsPhase 3BurnsNCT00643357
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
A Phase 3 study testing 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) and 50%Oxygen/50% Nitrogen premix in people with Burns, run by Air Liquide Santé International.
Trial summary
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Burns
- What is being tested?
- 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) and 50%Oxygen/50% Nitrogen premix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 3
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
- potentially mildly to moderately painful
- lasting for at least 15 minutes and for less than 30 minutes
- eligible to receive short-term prophylactic analgesic treatment
- for whom the consent form has been signed (parent and child)
Who cannot join
- Child treated under general anaesthesia
- Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
- Child suffering from moderate to severe pain when beginning the care procedure (FPSr > 4)
About this study
Official title: Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.
Read the detailed description
Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.
Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.
Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.
The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.
The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.
- Conditions
- Burns
- Being tested
- 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar), 50%Oxygen/50% Nitrogen premix
- Keywords
- children with burns, Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)Drug
gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
50%Oxygen/50% Nitrogen premixDrug
inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar) Receives: Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) |
| B | Placebo comparator | 50%Oxygen/50% Nitrogen premix Receives: Drug: 50%Oxygen/50% Nitrogen premix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
Measured: Faces Pain Scale Revised
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: No patient recruited due to current guidelines for the pain related to burn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643357
- Sponsor's protocol ID
- 2006-002698-38
- Acronym
- Burns
- Status last verified
- Jan 2012
- First submitted
- 19 Mar 2008
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns
- ClinicalTrials.gov ID
- NCT00643357
- Acronym / sponsor ID
- Burns / 2006-002698-38
- Conditions
- Burns
- Keywords
- children with burns, Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient recruited due to current guidelines for the pain related to burn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Mar 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.
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.
Detailed description
Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.
Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.
Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.
The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.
The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar) |
| B | Placebo comparator | Drug: 50%Oxygen/50% Nitrogen premix50%Oxygen/50% Nitrogen premix |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
Key exclusion criteria (3 listed)
- Child treated under general anaesthesia
- Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
- Child suffering from moderate to severe pain when beginning the care procedure (FPSr > 4)
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 |
|---|---|---|
| 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes | Drug | A |
| 50%Oxygen/50% Nitrogen premixinhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min | Drug | B |
Primary outcome
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
Time frame: Faces Pain Scale Revised
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 19 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) and 50%Oxygen/50% Nitrogen premix in people with Burns, run by Air Liquide Santé International.
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 5 inclusion and 3 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 19 Jan 2012. 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. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The intensity of the pain was assessed using the "Faces Pain Scale Revised" (time frame: Faces Pain Scale Revised). 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 19 Jan 2012.