DexT&A: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Study Details
Study Description
Brief Summary
The primary purpose of this study is:
-
To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
-
To determine an analgesic dose response relationship for dexmedetomidine.
-
Compare recovery characteristics of dexmedetomidine to fentanyl.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Fentanyl 1 Fentanyl 1 micrograms (mcg)/kilogram (kg) |
Drug: Fentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
Other Names:
|
Active Comparator: Fentanyl 2 Fentanyl 2 micrograms (mcg)/kilogram (kg) |
Drug: Fentanyl
Fentanyl 2mcg/kg, Intravenous (IV)
Other Names:
|
Experimental: Dex 3 Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) |
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
Other Names:
|
Experimental: Dex 4 Dexmedetomidine 4 micrograms (mcg)/kilogram (kg) |
Drug: Dexmedetomidine
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- All of the following criteria must be met for the potential subject to be eligible for participation:
-
The subject is 2 to 12 years of age
-
The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
-
The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
-
The subject will be hospitalized overnight after surgery
-
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 exclusion criteria apply:
-
The subject has a history or a family (parent or sibling) history of malignant hyperthermia
-
The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests.
-
The subject has a known or suspected allergy to opioid analgesics
-
The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
-
The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
Sponsors and Collaborators
- Children's National Research Institute
- Hospira, now a wholly owned subsidiary of Pfizer
Investigators
- Principal Investigator: Julia C Finkel, MD, Children's National Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3502
- Agreement #10698
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) |
---|---|---|---|---|
Arm/Group Description | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation |
Period Title: Overall Study | ||||
STARTED | 26 | 25 | 25 | 25 |
COMPLETED | 26 | 25 | 25 | 25 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | Total |
---|---|---|---|---|---|
Arm/Group Description | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation | Total of all reporting groups |
Overall Participants | 26 | 25 | 25 | 25 | 101 |
Age (Count of Participants) | |||||
<=18 years |
26
100%
|
25
100%
|
25
100%
|
25
100%
|
101
100%
|
Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
4.17
(2.33)
|
4.83
(2.45)
|
5.17
(2.33)
|
4.92
(2.27)
|
4.77
(2.34)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
9
34.6%
|
11
44%
|
12
48%
|
11
44%
|
43
42.6%
|
Male |
17
65.4%
|
14
56%
|
13
52%
|
14
56%
|
58
57.4%
|
Region of Enrollment (participants) [Number] | |||||
United States |
26
100%
|
25
100%
|
25
100%
|
25
100%
|
101
100%
|
Outcome Measures
Title | Time to First Morphine Dose |
---|---|
Description | Total minutes from study medication administration to time of first morphine dose. |
Time Frame | up to 24 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fentanyl 1 Microgram/Kilogram IV | Fentanyl 2 Micrograms/Kilogram IV | Dexmedetomidine 2 Microgram/Kilogram IV | Dexmedetomidine 4 Micrograms/Kilogram IV |
---|---|---|---|---|
Arm/Group Description | ||||
Measure Participants | 26 | 25 | 25 | 25 |
Mean (Standard Deviation) [minutes] |
19
(24.8)
|
43.7
(61.4)
|
61.1
(89.5)
|
137.6
(123.2)
|
Title | Morphine Rescue |
---|---|
Description | Total morphine administered in the Post Anesthesia Care Unit (PACU) |
Time Frame | up to 24 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) |
---|---|---|---|---|
Arm/Group Description | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation |
Measure Participants | 26 | 25 | 25 | 25 |
Mean (Standard Deviation) [micrograms/kilogram] |
84
(37)
|
95
(44)
|
85
(37)
|
59
(44)
|
Adverse Events
Time Frame | ||||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | ||||
Arm/Group Description | Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. | Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation | Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation | Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation | ||||
All Cause Mortality |
||||||||
Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/26 (0%) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/26 (0%) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Julia Finkel, MD |
---|---|
Organization | Children's National Medical Center |
Phone | 202-476-4867 ext 4867 |
jfinkel@cnmc.org |
- 3502
- Agreement #10698