Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their CarePhase 1NCT00232921
The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children
A Phase 1 study testing caudal volume 1, caudal volume 2 and caudal volume 3 in people with Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7 Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care
- What is being tested?
- caudal volume 1, caudal volume 2 and caudal volume 3
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento Feb 2003
- Phase
- Phase 1
- 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 and 2 patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7
- Being tested
- caudal volume 1, caudal volume 2, caudal volume 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal volume 1Drug
caudal volume 2Biological
caudal volume 3Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The radiographic height of the block post injection
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 completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their CareStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- NCT00232921
- Sponsor's protocol ID
- 02AR07
- Status last verified
- Dec 2006
- First submitted
- 4 Oct 2005
- Last updated
- 25 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children
- ClinicalTrials.gov ID
- NCT00232921
- Acronym / sponsor ID
- 02AR07
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study completion
- Feb 2003
- 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.
Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 and 2 patients
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 |
|---|---|---|
| caudal volume 1 | Drug | – |
| caudal volume 2 | Biological | – |
| caudal volume 3 | Drug | – |
Primary outcome
The radiographic height of the block post injection
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 25 Dec 2006.
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 Phase 1 study testing caudal volume 1, caudal volume 2 and caudal volume 3 in people with Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care, 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 25 Dec 2006. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The radiographic height of the block post injection. 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 25 Dec 2006.