TonsillitisPhase 4DexT&ANCT00654511
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
A Phase 4 study testing Fentanyl and Dexmedetomidine in people with Tonsillitis, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
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.
- Conditions
- Tonsillitis
- Being tested
- Fentanyl, Dexmedetomidine
- Keywords
- Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Actiq
Fentanyl 1mcg/kg, Intravenous (IV)
FentanylDrug
Also called Actiq
Fentanyl 2mcg/kg, Intravenous (IV)
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine, 4mcg/kg Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl 1 | Active comparator | Fentanyl 1 micrograms (mcg)/kilogram (kg) Receives: Drug: Fentanyl |
| Fentanyl 2 | Active comparator | Fentanyl 2 micrograms (mcg)/kilogram (kg) Receives: Drug: Fentanyl |
| Dex 3 | Experimental | Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) Receives: Drug: Dexmedetomidine |
| Dex 4 | Experimental | Dexmedetomidine 4 micrograms (mcg)/kilogram (kg) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Morphine Dose
Total minutes from study medication administration to time of first morphine dose.
Measured: up to 24 hours
Morphine Rescue
Total morphine administered in the Post Anesthesia Care Unit (PACU)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startJan 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Julia Finkel, Children's National Research Institute
- Investigators
- Julia C Finkel, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654511
- Sponsor's protocol ID
- 3502
- Other IDs
- Agreement #10698
- Acronym
- DexT&A
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2008
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.
PubMed 21461792