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This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine w/ midazolam | Experimental | Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR. |
|
| fentanyl w/ midazolam | Active Comparator | Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR. |
|
| dexmedetomidine w/o midazolam | Experimental | 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication. |
|
| fentanyl w/o midazolam | Active Comparator | 1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine (1 µg/kg) will be administered intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| FLACC Behavioral Pain Assessment Scale Scores | FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both | 30 mins. post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery From General Anesthesia | Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge. | 30 mins. post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17273114 | Background | Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. doi: 10.1097/01.PCC.0000257100.31779.41. | |
| 17646493 | Background | Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c. |
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Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine w/ Midazolam | Midazolam given orally pre-op and dexmedetomidine given intranasally in OR. |
| FG001 | Fentanyl w/ Midazolam | Midazolam given orally pre-op and fentanyl given intranasally in OR. |
| FG002 | Dexmedetomidine w/o Midazolam | Dexmedetomidine given intranasally in OR without any pre-medication. |
| FG003 | Fentanyl w/o Midazolam | Fentanyl given intranasally in the OR without any pre-medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine w/ Midazolam | Midazolam given orally pre-op and dexmedetomidine given intranasally in OR. |
| BG001 | Fentanyl w/ Midazolam | Midazolam given orally pre-op and fentanyl given intranasally in OR. |
| 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 | FLACC Behavioral Pain Assessment Scale Scores | FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both | Posted | Mean | Standard Deviation | units on a scale | 30 mins. post-op |
|
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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 w/ Midazolam | Midazolam given orally pre-op and dexmedetomidine given intranasally in OR. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | Nationwide Children's Hospital | 614-722-4200 | Joseph.Tobias@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | fentanyl (2 µg/kg) will be administered intranasally |
|
| Midazolam | Drug | Sedative given pre-op. |
|
|
| BG002 | Dexmedetomidine w/o Midazolam | Dexmedetomidine given intranasally in OR without any pre-medication. |
| BG003 | Fentanyl w/o Midazolam | Fentanyl given intranasally in the OR without any pre-medication. |
| 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 |
|
| OG002 | Dexmedetomidine w/o Midazolam | Dexmedetomidine given intranasally in OR without any pre-medication. |
| OG003 | Fentanyl w/o Midazolam | Fentanyl given intranasally in the OR without any pre-medication. |
|
|
| Secondary | Recovery From General Anesthesia | Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge. | Posted | Mean | Standard Deviation | units on a scale | 30 mins. post-op |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Fentanyl w/ Midazolam | Midazolam given orally pre-op and fentanyl given intranasally in OR. | 0 | 25 | 0 | 25 |
| EG002 | Dexmedetomidine w/o Midazolam | Dexmedetomidine given intranasally in OR without any pre-medication. | 0 | 25 | 0 | 25 |
| EG003 | Fentanyl w/o Midazolam | Fentanyl given intranasally in the OR without any pre-medication. | 0 | 25 | 0 | 25 |
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| D010880 |
| Piperidines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |