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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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The primary purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl 1 | Active Comparator | Fentanyl 1 micrograms (mcg)/kilogram (kg) |
|
| Fentanyl 2 | Active Comparator | Fentanyl 2 micrograms (mcg)/kilogram (kg) |
|
| Dex 3 | Experimental | Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) |
|
| Dex 4 | Experimental | Dexmedetomidine 4 micrograms (mcg)/kilogram (kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl 1mcg/kg, Intravenous (IV) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Morphine Dose | Total minutes from study medication administration to time of first morphine dose. | up to 24 hours |
| Morphine Rescue | Total morphine administered in the Post Anesthesia Care Unit (PACU) | up to 24 hours |
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Inclusion Criteria:
All of the following criteria must be met for the potential subject to be eligible for participation:
The subject is 2 to 12 years of age
The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
The subject will be hospitalized overnight after surgery
The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.
Exclusion Criteria:
The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21461792 | Derived | Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. |
| FG001 | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation |
| FG002 | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation |
| FG003 | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. |
| BG001 | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) |
| 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 | Time to First Morphine Dose | Total minutes from study medication administration to time of first morphine dose. | Posted | Mean | Standard Deviation | minutes | 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 | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Finkel, MD | Children's National Medical Center | 202-476-4867 | 4867 | jfinkel@cnmc.org |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
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| Fentanyl | Drug | Fentanyl 2mcg/kg, Intravenous (IV) |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine, 2mcg/kg, Intravenous (IV) |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine, 4mcg/kg Intravenous (IV) |
|
|
Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
| BG002 | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation |
| BG003 | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation |
| 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 |
|
|
|
| Primary | Morphine Rescue | Total morphine administered in the Post Anesthesia Care Unit (PACU) | Posted | Mean | Standard Deviation | micrograms/kilogram | up to 24 hours |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | 0 | 25 | 0 | 25 |
| EG002 | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | 0 | 25 | 0 | 25 |
| EG003 | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation | 0 | 25 | 0 | 25 |
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001393 |
| Azoles |