Chronic Otitis Media
Conditions
Keywords
myringotomy, pressure equalization tubes
Brief summary
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.
Interventions
DRUGDexmedetomidine
dexmedetomidine (1 µg/kg) will be administered intranasally
DRUGFentanyl
fentanyl (2 µg/kg) will be administered intranasally
DRUGMidazolam
Sedative given pre-op.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease) * patients scheduled for placement of bilateral myringotomy tubes
Exclusion criteria
* history of allergy to either dexmedetomidine or fentanyl * concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC Behavioral Pain Assessment Scale Scores | 30 mins. post-op | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery From General Anesthesia | 30 mins. post-op | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital.
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine w/ Midazolam Midazolam given orally pre-op and dexmedetomidine given intranasally in OR. | 25 |
| Fentanyl w/ Midazolam Midazolam given orally pre-op and fentanyl given intranasally in OR. | 25 |
| Dexmedetomidine w/o Midazolam Dexmedetomidine given intranasally in OR without any pre-medication. | 25 |
| Fentanyl w/o Midazolam Fentanyl given intranasally in the OR without any pre-medication. | 25 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Pharmacy issues | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Dexmedetomidine w/ Midazolam | Fentanyl w/o Midazolam | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 25 Participants | 25 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3 years STANDARD_DEVIATION 2.02 | 2.98 years STANDARD_DEVIATION 1.87 | 2.14 years STANDARD_DEVIATION 1.01 | 2.22 years STANDARD_DEVIATION 1.16 | 3 years STANDARD_DEVIATION 1.59 |
| Region of Enrollment United States | 25 participants | 25 participants | 25 participants | 25 participants | 100 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 10 Participants | 5 Participants | 38 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 15 Participants | 20 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 30 mins. post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine w/ Midazolam | FLACC Behavioral Pain Assessment Scale Scores | 5 units on a scale | Standard Deviation 4.19 |
| Fentanyl w/ Midazolam | FLACC Behavioral Pain Assessment Scale Scores | 3 units on a scale | Standard Deviation 3.6 |
| Dexmedetomidine w/o Midazolam | FLACC Behavioral Pain Assessment Scale Scores | 1 units on a scale | Standard Deviation 2.2 |
| Fentanyl w/o Midazolam | FLACC Behavioral Pain Assessment Scale Scores | 2 units on a scale | Standard Deviation 2.92 |
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.
Time frame: 30 mins. post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine w/ Midazolam | Recovery From General Anesthesia | 8.67 units on a scale | Standard Deviation 1.33 |
| Fentanyl w/ Midazolam | Recovery From General Anesthesia | 9 units on a scale | Standard Deviation 0.96 |
| Dexmedetomidine w/o Midazolam | Recovery From General Anesthesia | 9.25 units on a scale | Standard Deviation 0.94 |
| Fentanyl w/o Midazolam | Recovery From General Anesthesia | 9.5 units on a scale | Standard Deviation 0.74 |