Trial Outcomes & Findings for Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement (NCT NCT01188551)
NCT ID: NCT01188551
Last Updated: 2014-04-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
100 participants
Primary outcome timeframe
30 mins. post-op
Results posted on
2014-04-01
Participant Flow
Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital.
Participant milestones
| Measure |
Dexmedetomidine w/ Midazolam
Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
|
Fentanyl w/ Midazolam
Midazolam given orally pre-op and fentanyl given intranasally in OR.
|
Dexmedetomidine w/o Midazolam
Dexmedetomidine given intranasally in OR without any pre-medication.
|
Fentanyl w/o Midazolam
Fentanyl given intranasally in the OR without any pre-medication.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dexmedetomidine w/ Midazolam
Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
|
Fentanyl w/ Midazolam
Midazolam given orally pre-op and fentanyl given intranasally in OR.
|
Dexmedetomidine w/o Midazolam
Dexmedetomidine given intranasally in OR without any pre-medication.
|
Fentanyl w/o Midazolam
Fentanyl given intranasally in the OR without any pre-medication.
|
|---|---|---|---|---|
|
Overall Study
Pharmacy issues
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
Baseline characteristics by cohort
| Measure |
Dexmedetomidine w/ Midazolam
n=25 Participants
Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
|
Fentanyl w/ Midazolam
n=25 Participants
Midazolam given orally pre-op and fentanyl given intranasally in OR.
|
Dexmedetomidine w/o Midazolam
n=25 Participants
Dexmedetomidine given intranasally in OR without any pre-medication.
|
Fentanyl w/o Midazolam
n=25 Participants
Fentanyl given intranasally in the OR without any pre-medication.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
2.14 years
STANDARD_DEVIATION 1.01 • n=5 Participants
|
3 years
STANDARD_DEVIATION 2.02 • n=7 Participants
|
2.98 years
STANDARD_DEVIATION 1.87 • n=5 Participants
|
2.22 years
STANDARD_DEVIATION 1.16 • n=4 Participants
|
3 years
STANDARD_DEVIATION 1.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 mins. post-opFLACC 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
Outcome measures
| Measure |
Dexmedetomidine w/ Midazolam
n=24 Participants
Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
|
Fentanyl w/ Midazolam
n=25 Participants
Midazolam given orally pre-op and fentanyl given intranasally in OR.
|
Dexmedetomidine w/o Midazolam
n=25 Participants
Dexmedetomidine given intranasally in OR without any pre-medication.
|
Fentanyl w/o Midazolam
n=25 Participants
Fentanyl given intranasally in the OR without any pre-medication.
|
|---|---|---|---|---|
|
FLACC Behavioral Pain Assessment Scale Scores
|
5 units on a scale
Standard Deviation 4.19
|
3 units on a scale
Standard Deviation 3.60
|
1 units on a scale
Standard Deviation 2.20
|
2 units on a scale
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: 30 mins. post-opPost-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.
Outcome measures
| Measure |
Dexmedetomidine w/ Midazolam
n=24 Participants
Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
|
Fentanyl w/ Midazolam
n=25 Participants
Midazolam given orally pre-op and fentanyl given intranasally in OR.
|
Dexmedetomidine w/o Midazolam
n=25 Participants
Dexmedetomidine given intranasally in OR without any pre-medication.
|
Fentanyl w/o Midazolam
n=25 Participants
Fentanyl given intranasally in the OR without any pre-medication.
|
|---|---|---|---|---|
|
Recovery From General Anesthesia
|
8.67 units on a scale
Standard Deviation 1.33
|
9 units on a scale
Standard Deviation 0.96
|
9.25 units on a scale
Standard Deviation 0.94
|
9.5 units on a scale
Standard Deviation 0.74
|
Adverse Events
Dexmedetomidine w/ Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl w/ Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine w/o Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl w/o Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place