ASA 1-2 Requiring Intravenous Cannulation for General AnaesthesiaNCT00232895
Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years
A study testing lipuro propofol and standard formulation propofol in people with ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia
- What is being tested?
- lipuro propofol and standard formulation propofol
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento Aug 2005
- 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 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1 or 2 requiring intravenous general anaesthetic
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation
- Being tested
- lipuro propofol, standard formulation propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipuro propofolDrug
standard formulation propofolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores on induction of anaesthesia with propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA 1-2 Requiring Intravenous Cannulation for General AnaesthesiaStudies 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Mark Thomas, Dr, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232895
- Sponsor's protocol ID
- 02AR36
- Status last verified
- Mar 2007
- First submitted
- 4 Oct 2005
- Last updated
- 28 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years
- ClinicalTrials.gov ID
- NCT00232895
- Acronym / sponsor ID
- 02AR36
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study completion
- Aug 2005
- First posted
- 5 Oct 2005 (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.
Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA 1 or 2 requiring intravenous general anaesthetic
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| lipuro propofol | Drug | – |
| standard formulation propofol | Drug | – |
Primary outcome
pain scores on induction of anaesthesia with propofol
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 28 Mar 2007.
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.
Mark Thomas, Dr principal investigator
Great Ormond Street 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 lipuro propofol and standard formulation propofol in people with ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia, run by Institute of Child Health at 1 site in United Kingdom.
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 28 Mar 2007. 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 Kingdom. 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.
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?
pain scores on induction of anaesthesia with propofol. 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 28 Mar 2007.