SedationNCT00878345
Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
A study testing dexmedetomidine sedation protocol and pentobarbital sedation protocol in people with Sedation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Sedation
- What is being tested?
- dexmedetomidine sedation protocol and pentobarbital sedation protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2010
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Requiring sedation for non-painful procedures
- Normal airway per exam
Who cannot join
- Congenital syndromes with known difficult airways
- Known difficult airway during past anesthesia or sedation experience
- Parent/guardian refusal of participation
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics
The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.
- Conditions
- Sedation
- Being tested
- dexmedetomidine sedation protocol, pentobarbital sedation protocol
- Keywords
- Pediatric sedation, Pentobarbital, Dexmedetomidine, Procedural sedation in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine sedation protocolDrug
Also called Precedex
Arm 1 will undergo sedation with dexmedetomidine, using 2 mcg/kg load IV over 10 minutes followed by an IV infusion of 1 mcg/kg/hr. May use versed 0.5 mg/kg IV x 1 for incomplete sedation, followed by increase of dexmedetomidine infusion to 1.5 mcg/kg/hr. Infusion will run throughout non-painful procedure (most likely MRI).
pentobarbital sedation protocolDrug
Also called Nembutal
Pentobarbital Sedation Protocol IV: 2.5 mg/kg, followed by 1.25 mg/kg as needed x2. Maintenance: May give additional 1.25 mg/kg IV x 2 if needed. Max total dose of 200 mg pentobarbital throughout sedation.
May give midazolam 0.05 mg/kg IV x 1 PRN agitation for rescue sedation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dexmedetomidine sedation protocol Receives: Drug: dexmedetomidine sedation protocol |
| 2 | Active comparator | Pentobarbital sedation protocol Receives: Drug: pentobarbital sedation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of sedation
Measured: day of sedation
Secondary outcomes (2)
side effect profile
Measured: 48 hours
post-sedation recovery and discharge time
Measured: day of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: Study was never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878345
- Sponsor's protocol ID
- colegroenersterni
- Status last verified
- Jun 2018
- First submitted
- 7 Apr 2009
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.
PubMed 18363628Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. doi: 10.1213/01.ANE.0000228303.92422.73. No abstract available.
PubMed 16790665Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
PubMed 16790627
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics
- ClinicalTrials.gov ID
- NCT00878345
- Acronym / sponsor ID
- colegroenersterni
- Conditions
- Sedation
- Keywords
- Pediatric sedation, Pentobarbital, Dexmedetomidine, Procedural sedation in children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 8 Apr 2009 (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 investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: dexmedetomidine sedation protocolDexmedetomidine sedation protocol |
| 2 | Active comparator | Drug: pentobarbital sedation protocolPentobarbital sedation protocol |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Requiring sedation for non-painful procedures
- Normal airway per exam
Key exclusion criteria (3 listed)
- Congenital syndromes with known difficult airways
- Known difficult airway during past anesthesia or sedation experience
- Parent/guardian refusal of participation
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 |
|---|---|---|
| dexmedetomidine sedation protocolAlso: PrecedexArm 1 will undergo sedation with dexmedetomidine, using 2 mcg/kg load IV over 10 minutes followed by an IV infusion of 1 mcg/kg/hr. May use versed 0.5 mg/kg IV x 1 for incomplete sedation, followed by increase of dexmedetomidine infusion to 1.5 mcg/kg/hr. Infusion will run throughout non-painful procedure (most likely MRI). | Drug | 1 |
| pentobarbital sedation protocolAlso: NembutalPentobarbital Sedation Protocol IV: 2.5 mg/kg, followed by 1.25 mg/kg as needed x2. Maintenance: May give additional 1.25 mg/kg IV x 2 if needed. Max total dose of 200 mg pentobarbital throughout sedation. May give midazolam 0.05 mg/kg IV x 1 PRN agitation for rescue sedation. | Drug | 2 |
Primary outcome
failure of sedation
Time frame: day of sedation
2 secondary outcomes
side effect profile
Time frame: 48 hours
post-sedation recovery and discharge time
Time frame: day of sedation
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 28 Jun 2018.
- Background: PubMed 18363628Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.
- Background: PubMed 16790665Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. doi: 10.1213/01.ANE.0000228303.92422.73. No abstract available.
- Background: PubMed 16790627Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine sedation protocol and pentobarbital sedation protocol in people with Sedation, run by Washington University School of Medicine at 1 site in United States.
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 2 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 28 Jun 2018. 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 States. 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 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?
failure of sedation (time frame: day of sedation). 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 NCT00878345, which also lists 3 linked publications.
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 Jun 2018.