Hematologic DiseasesPhase 1/2NCT00213239
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
A Phase 1/2 study testing Remifentanil in people with Hematologic Diseases and Neoplasms, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Hematologic Diseases, Neoplasms
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jan 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 4-11 years
- Male or female
- Unpremedicated
- Willing and able to provide informed consent (or informed consent by parents)
Who cannot join
- Children who are known or suspected to be difficult to ventilate by face mask
- Children who are deemed medically unfit to receive either of the two study medications
- Children who are obese (weight for height > 95th percentile,
- Children who do not have an indwelling intravenous line
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
Read the detailed description
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.
- Conditions
- Hematologic Diseases, Neoplasms
- Being tested
- Remifentanil
- Keywords
- spinal puncture, remifentanil, propofol, anesthesia, dose finding, pediatrics
- Medical subject headings
- Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
RemifentanilDrug
The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
| Study group | Role | What they receive |
|---|---|---|
| Propofol 4 mg/kg group | Experimental | First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) Receives: Drug: Remifentanil |
| Propofol 2 mg/kg group | Experimental | First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion
Measured: Movement measured at the time of lumbar puncture needle insertion.
Secondary outcomes (1)
Incidence of Adverse Events.
Measured: Followed for the length of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hayes, The Hospital for Sick Children
- Investigators
- Jason Hayes, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213239
- Sponsor's protocol ID
- 1000007479
- Status last verified
- Nov 2019
- First submitted
- 13 Sep 2005
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hayes JA, Lopez AV, Pehora CM, Robertson JM, Abla O, Crawford MW. Coadministration of propofol and remifentanil for lumbar puncture in children: dose-response and an evaluation of two dose combinations. Anesthesiology. 2008 Oct;109(4):613-8. doi: 10.1097/ALN.0b013e31818629f3.
PubMed 18813039
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
- ClinicalTrials.gov ID
- NCT00213239
- Acronym / sponsor ID
- 1000007479
- Conditions
- Hematologic Diseases, Neoplasms
- Keywords
- spinal puncture, remifentanil, propofol, anesthesia, dose finding, pediatrics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
Detailed description
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol 4 mg/kg group | Experimental | Drug: RemifentanilFirst patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) |
| Propofol 2 mg/kg group | Experimental | Drug: RemifentanilFirst patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 4-11 years
- Male or female
- Unpremedicated
Key exclusion criteria (4 listed)
- Children who are known or suspected to be difficult to ventilate by face mask
- Children who are deemed medically unfit to receive either of the two study medications
- Children who are obese (weight for height > 95th percentile,
- Children who do not have an indwelling intravenous line
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 |
|---|---|---|
| RemifentanilThe first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. | Drug | Propofol 4 mg/kg group |
| RemifentanilThe first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. | Drug | Propofol 2 mg/kg group |
Primary outcome
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
Time frame: Movement measured at the time of lumbar puncture needle insertion.
Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion
1 secondary outcome
Incidence of Adverse Events.
Time frame: Followed for the length of the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18813039Hayes JA, Lopez AV, Pehora CM, Robertson JM, Abla O, Crawford MW. Coadministration of propofol and remifentanil for lumbar puncture in children: dose-response and an evaluation of two dose combinations. Anesthesiology. 2008 Oct;109(4):613-8. doi: 10.1097/ALN.0b013e31818629f3.
- Published October 2008Link provided by the sponsor.
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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.
Jason Hayes, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remifentanil in people with Hematologic Diseases and Neoplasms, run by The Hospital for Sick Children at 1 site in Canada.
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 4 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 2 Dec 2019. 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 Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion (time frame: Movement measured at the time of lumbar puncture needle insertion.). 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 NCT00213239, 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 2 Dec 2019.