Tonsillitis
Conditions
Keywords
Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,
Brief summary
The primary purpose of this study is: 1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia. 2. To determine an analgesic dose response relationship for dexmedetomidine. 3. Compare recovery characteristics of dexmedetomidine to fentanyl.
Interventions
DRUGFentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
DRUGDexmedetomidine
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
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, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* All of the following criteria must be met for the potential subject to be eligible for participation: 1. The subject is 2 to 12 years of age 2. The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1). 3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed). 4. The subject will be hospitalized overnight after surgery 5. The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.
Exclusion criteria
* The potential subject is NOT eligible for participation if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Morphine Dose | up to 24 hours | Total minutes from study medication administration to time of first morphine dose. |
| Morphine Rescue | up to 24 hours | Total morphine administered in the Post Anesthesia Care Unit (PACU) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. | 26 |
| Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | 25 |
| Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | 25 |
| Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation | 25 |
| Total | 101 |
Baseline characteristics
| Characteristic | Total | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 26 Participants | 25 Participants | 25 Participants | 25 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 | 4.77 years STANDARD_DEVIATION 2.34 | 4.17 years STANDARD_DEVIATION 2.33 | 4.83 years STANDARD_DEVIATION 2.45 | 5.17 years STANDARD_DEVIATION 2.33 | 4.92 years STANDARD_DEVIATION 2.27 |
| Region of Enrollment United States | 101 participants | 26 participants | 25 participants | 25 participants | 25 participants |
| Sex: Female, Male Female | 43 Participants | 9 Participants | 11 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Male | 58 Participants | 17 Participants | 14 Participants | 13 Participants | 14 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 / 26 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Morphine Rescue
Total morphine administered in the Post Anesthesia Care Unit (PACU)
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl 1 Microgram/Kilogram IV | Morphine Rescue | 84 micrograms/kilogram | Standard Deviation 37 |
| Fentanyl 2 Micrograms/Kilogram IV | Morphine Rescue | 95 micrograms/kilogram | Standard Deviation 44 |
| Dexmedetomidine 2 Microgram/Kilogram IV | Morphine Rescue | 85 micrograms/kilogram | Standard Deviation 37 |
| Dexmedetomidine 4 Micrograms/Kilogram IV | Morphine Rescue | 59 micrograms/kilogram | Standard Deviation 44 |
Primary
Time to First Morphine Dose
Total minutes from study medication administration to time of first morphine dose.
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl 1 Microgram/Kilogram IV | Time to First Morphine Dose | 19 minutes | Standard Deviation 24.8 |
| Fentanyl 2 Micrograms/Kilogram IV | Time to First Morphine Dose | 43.7 minutes | Standard Deviation 61.4 |
| Dexmedetomidine 2 Microgram/Kilogram IV | Time to First Morphine Dose | 61.1 minutes | Standard Deviation 89.5 |
| Dexmedetomidine 4 Micrograms/Kilogram IV | Time to First Morphine Dose | 137.6 minutes | Standard Deviation 123.2 |