AnesthesiaPhase 3NCT00287560
Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
A Phase 3 study testing propofol (drug) in people with Anesthesia, run by B. Braun Melsungen AG.
Trial summary
The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- propofol (drug)
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Feb 2005
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age >= 2 and < 6 years
- written informed consent of the parents
- anesthetic risc classified as ASA I - III
- patient undergoing elective surgery under general anesthesia
- venous access for induction of anesthesia on the dorsum of the hand
- hospital care for at least 3 hrs after end of anesthesia guaranteed
Who cannot join
- intolerability of the drugs tested
- current drug medication with sedative effect
- patient is expected to require concomitant medication not allowed in the study
- history of or current renal or hepatic disease, cardiac insufficiency
- hypovolemia
- increased cranial pressure
- simultaneous participation in another clinical trial or participation during the month preceding this study
About this study
Official title: A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Read the detailed description
Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
- Conditions
- Anesthesia
- Being tested
- propofol (drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of spontaneous expression of pain during injection
Secondary outcomes (1)
anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startAug 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerd P Molter, MD, PhD, Principal investigator, Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287560
- Sponsor's protocol ID
- BBMDE-0312
- Status last verified
- Feb 2008
- First submitted
- 6 Feb 2006
- Last updated
- 25 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
- ClinicalTrials.gov ID
- NCT00287560
- Acronym / sponsor ID
- BBMDE-0312
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Feb 2005
- First posted
- 7 Feb 2006 (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 the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Detailed description
Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age >= 2 and < 6 years
- written informed consent of the parents
- anesthetic risc classified as ASA I - III
- patient undergoing elective surgery under general anesthesia
- venous access for induction of anesthesia on the dorsum of the hand
Key exclusion criteria (7 listed)
- intolerability of the drugs tested
- current drug medication with sedative effect
- patient is expected to require concomitant medication not allowed in the study
- history of or current renal or hepatic disease, cardiac insufficiency
- hypovolemia
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 |
|---|---|---|
| propofol (drug) | Drug | – |
Primary outcome
incidence of spontaneous expression of pain during injection
1 secondary outcome
anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
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 Feb 2008.
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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.
Gerd P Molter, MD, PhD principal investigator
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propofol (drug) in people with Anesthesia, run by B. Braun Melsungen AG.
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 6 inclusion and 7 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 Feb 2008. 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.
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 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?
incidence of spontaneous expression of pain during 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 Feb 2008.