Otitis
Conditions
Keywords
Dexmedetomidine, transmucosal, myringotomy,
Brief summary
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
Interventions
DRUGSaline
Normal saline, given intranasally
DRUGFentanyl
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
DRUGDexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Children's National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must meet all of the following inclusion criteria to be eligible for participation: 1. The subject is 6 months to 6 years of age 2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1) 3. The subject is scheduled for elective bilateral myringotomy with tube placement 4. The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion criteria
* Subjects will be excluded from study participation if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pain | up to 24 hours | Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in PACU | up to 24 hours | Total time from PACU entry until discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine 1microgram/Kilogram Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal | 23 |
| Dexmedetomidine 2 Micrograms/Kilogram Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal | 28 |
| Fentanyl 2 Micrograms/Kilogram Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal | 23 |
| Normal Saline Placebo Normal saline placebo intranasal | 27 |
| Total | 101 |
Baseline characteristics
| Characteristic | Dexmedetomidine 2 Micrograms/Kilogram | Fentanyl 2 Micrograms/Kilogram | Dexmedetomidine 1microgram/Kilogram | Normal Saline Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 23 Participants | 23 Participants | 27 Participants | 101 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 | 2.17 years STANDARD_DEVIATION 1.51 | 2.25 years STANDARD_DEVIATION 1.47 | 1.92 years STANDARD_DEVIATION 0.94 | 2.17 years STANDARD_DEVIATION 1.66 | 2.14 years STANDARD_DEVIATION 1.42 |
| Region of Enrollment United States | 28 participants | 23 participants | 23 participants | 27 participants | 101 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 5 Participants | 10 Participants | 35 Participants |
| Sex: Female, Male Male | 18 Participants | 13 Participants | 18 Participants | 17 Participants | 66 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 / 23 | 1 / 28 | 0 / 23 | 0 / 27 |
| serious Total, serious adverse events | 0 / 23 | 0 / 28 | 0 / 23 | 0 / 27 |
Outcome results
Primary
Incidence of Pain
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)
Time frame: up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine 1microgram/Kilogram | Incidence of Pain | 6 participants |
| Dexmedetomidine 2 Micrograms/Kilogram | Incidence of Pain | 11 participants |
| Fentanyl 2 Micrograms/Kilogram | Incidence of Pain | 7 participants |
| Normal Saline Placebo | Incidence of Pain | 18 participants |
Secondary
Length of Stay in PACU
Total time from PACU entry until discharge
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine 1microgram/Kilogram | Length of Stay in PACU | 48 minutes | Standard Deviation 26 |
| Dexmedetomidine 2 Micrograms/Kilogram | Length of Stay in PACU | 88 minutes | Standard Deviation 69 |
| Fentanyl 2 Micrograms/Kilogram | Length of Stay in PACU | 46 minutes | Standard Deviation 25 |
| Normal Saline Placebo | Length of Stay in PACU | 48 minutes | Standard Deviation 27 |