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| ID | Type | Description | Link |
|---|---|---|---|
| Agreement # 10698 |
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 1microgram/kilogram | Experimental | Dexmedetomidine 1microgram/kilogram intranasal |
|
| Dexmedetomidine 2 micrograms/kilogram | Experimental | Dexmedetomidine 2 micrograms/kilogram intranasal |
|
| Fentanyl 2 micrograms/kilogram | Active Comparator | Fentanyl 2 micrograms/kilogram intranasal |
|
| Normal saline placebo | Placebo Comparator | Normal saline placebo intranasal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Normal saline, given intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pain | Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU) | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in PACU | Total time from PACU entry until discharge | up to 24 hours |
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Inclusion Criteria:
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
Exclusion Criteria:
Subjects will be excluded from study participation if any of the following exclusion criteria exists:
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| Name | Affiliation | Role |
|---|---|---|
| Julia C Finkel, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine 1microgram/Kilogram | Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal |
| FG001 | Dexmedetomidine 2 Micrograms/Kilogram | Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal |
| FG002 | Fentanyl 2 Micrograms/Kilogram | Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal |
| FG003 | Normal Saline Placebo | Normal saline placebo intranasal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine 1microgram/Kilogram | Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal |
| BG001 | Dexmedetomidine 2 Micrograms/Kilogram | Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Pain | Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU) | Posted | Number | participants | up to 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine 1microgram/Kilogram | Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate dropped to 42 bpm for 2 min post-op. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia C. Finkel, MD | Children's National Medical Center | 202-476-4867 | 4867 | jfinkel@cnmc.org |
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| ID | Term |
|---|---|
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Fentanyl | Drug | Fentanyl, nasal transmucosal, 2 micrograms/kilogram |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine, transmucosal, 1 microgram/kilogram |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine, 2 microgram/kilogram, transmucosal route |
|
|
| BG002 | Fentanyl 2 Micrograms/Kilogram | Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal |
| BG003 | Normal Saline Placebo | Normal saline placebo intranasal |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Normal Saline Placebo | Normal saline placebo intranasal |
|
|
| Secondary | Length of Stay in PACU | Total time from PACU entry until discharge | Posted | Mean | Standard Deviation | minutes | up to 24 hours |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Dexmedetomidine 2 Micrograms/Kilogram | Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal | 0 | 28 | 1 | 28 |
| EG002 | Fentanyl 2 Micrograms/Kilogram | Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal | 0 | 23 | 0 | 23 |
| EG003 | Normal Saline Placebo | Normal saline placebo intranasal | 0 | 27 | 0 | 27 |
|
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| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |