A Phase 2/3 interventional study of Dexmedetomidine and Fentanyl in Chronic Otitis Media, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-04-01.
Sponsored by Nationwide Children's Hospital · Phase 2/3, Interventional, and Treatment
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.
Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
Drug: Dexmedetomidine · Drug: Midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
Drug: Fentanyl · Drug: Midazolam
1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
Drug: Dexmedetomidine
1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.
Drug: Fentanyl
dexmedetomidine (1 µg/kg) will be administered intranasally
Also known as: Precedex
fentanyl (2 µg/kg) will be administered intranasally
Sedative given pre-op.
Also known as: Versed
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
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
Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital.
| Milestone | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam |
|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 |
| Completed | 24 | 25 | 25 | 25 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Pharmacy issues | 1 | 0 | 0 | 0 |
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
| units on a scale | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam |
|---|---|---|---|---|
| FLACC Behavioral Pain Assessment Scale Scores | 5 ± 4.19 | 3 ± 3.60 | 1 ± 2.20 | 2 ± 2.92 |
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.
| units on a scale | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam |
|---|---|---|---|---|
| Recovery From General Anesthesia | 8.67 ± 1.33 | 9 ± 0.96 | 9.25 ± 0.94 | 9.5 ± 0.74 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine w/ Midazolam | — | 0/25 (0%) | 0/25 (0%) |
| Fentanyl w/ Midazolam | — | 0/25 (0%) | 0/25 (0%) |
| Dexmedetomidine w/o Midazolam | — | 0/25 (0%) | 0/25 (0%) |
| Fentanyl w/o Midazolam | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam | Total |
|---|---|---|---|---|---|
| <=18 years | 25 | 25 | 25 | 25 | 100 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam | Total |
|---|---|---|---|---|---|
| Mean | 2.14 ± 1.01 | 3 ± 2.02 | 2.98 ± 1.87 | 2.22 ± 1.16 | 3 ± 1.59 |
| Sex: Female, Male(Participants) | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam | Total |
|---|---|---|---|---|---|
| Female | 10 | 14 | 9 | 5 | 38 |
| Male | 15 | 11 | 16 | 20 | 62 |
| Region of Enrollment(participants) | Dexmedetomidine w/ Midazolam | Fentanyl w/ Midazolam | Dexmedetomidine w/o Midazolam | Fentanyl w/o Midazolam | Total |
|---|---|---|---|---|---|
| United States | 25 | 25 | 25 | 25 | 100 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Midazolam
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