OtitisPhase 4DexBMTNCT00654329
Dexmedetomidine vs Fentanyl for BMT
A Phase 4 study testing Saline, Fentanyl and Dexmedetomidine in people with Otitis, run by Children's National Research Institute at 1 site in United States.
Trial summary
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis
- What is being tested?
- Saline, Fentanyl and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2008
- Phase
- Phase 4
- 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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
- The subject is 6 months to 6 years of age
- The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
- The subject is scheduled for elective bilateral myringotomy with tube placement
- The subject's parent/legally authorized guardian has given written informed consent to participate
Who cannot join
- Subjects will be excluded from study participation if any of the following exclusion criteria exists:
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
- The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
- The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
- The subject has know central nervous system disease or neurological impairment
Show all 10Show fewer
- The subject is an ASA classification of 3 or greater (See Appendix 1)
- The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
- The subject refuses inhalation induction
- The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
- Conditions
- Otitis
- Being tested
- Saline, Fentanyl, Dexmedetomidine
- Keywords
- Dexmedetomidine, transmucosal, myringotomy,
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Normal Saline
Normal saline, given intranasally
FentanylDrug
Also called Actiq, Fentora
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine, transmucosal, 1 microgram/kilogram
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 1microgram/kilogram | Experimental | Dexmedetomidine 1microgram/kilogram intranasal Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 2 micrograms/kilogram | Experimental | Dexmedetomidine 2 micrograms/kilogram intranasal Receives: Drug: Dexmedetomidine |
| Fentanyl 2 micrograms/kilogram | Active comparator | Fentanyl 2 micrograms/kilogram intranasal Receives: Drug: Fentanyl |
| Normal saline placebo | Placebo comparator | Normal saline placebo intranasal Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pain
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)
Measured: up to 24 hours
Secondary outcomes (1)
Length of Stay in PACU
Total time from PACU entry until discharge
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2008
- Study completionDec 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.
- Other trials for OtitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Investigators
- Julia C Finkel, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654329
- Sponsor's protocol ID
- 3641
- Other IDs
- Agreement # 10698
- Acronym
- DexBMT
- Status last verified
- Mar 2011
- First submitted
- 3 Apr 2008
- Last updated
- 25 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
- ClinicalTrials.gov ID
- NCT00654329
- Acronym / sponsor ID
- DexBMT / 3641
- Conditions
- Otitis
- Keywords
- Dexmedetomidine, transmucosal, myringotomy,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Posted 25 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 1microgram/kilogram | Experimental | Drug: DexmedetomidineDexmedetomidine 1microgram/kilogram intranasal |
| Dexmedetomidine 2 micrograms/kilogram | Experimental | Drug: DexmedetomidineDexmedetomidine 2 micrograms/kilogram intranasal |
| Fentanyl 2 micrograms/kilogram | Active comparator | Drug: FentanylFentanyl 2 micrograms/kilogram intranasal |
| Normal saline placebo | Placebo comparator | Drug: SalineNormal saline placebo intranasal |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
Key exclusion criteria (10 listed)
- Subjects will be excluded from study participation if any of the following exclusion criteria exists:
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 |
|---|---|---|
| SalineAlso: Normal SalineNormal saline, given intranasally | Drug | Normal saline placebo |
| FentanylAlso: Actiq, FentoraFentanyl, nasal transmucosal, 2 micrograms/kilogram | Drug | Fentanyl 2 micrograms/kilogram |
| DexmedetomidineAlso: PrecedexDexmedetomidine, transmucosal, 1 microgram/kilogram | Drug | Dexmedetomidine 1microgram/kilogram |
| DexmedetomidineAlso: PrecedexDexmedetomidine, 2 microgram/kilogram, transmucosal route | Drug | Dexmedetomidine 2 micrograms/kilogram |
Primary outcome
Incidence of Pain
Time frame: up to 24 hours
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)
1 secondary outcome
Length of Stay in PACU
Time frame: up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julia C Finkel, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline, Fentanyl and Dexmedetomidine in people with Otitis, run by Children's National Research Institute 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 5 inclusion and 10 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 Apr 2011. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 25 Apr 2011). 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?
Incidence of Pain (time frame: up to 24 hours). 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 Apr 2011.