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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
- ClinicalTrials.gov ID
- NCT00654511
- Acronym / sponsor ID
- DexT&A / 3502
- Conditions
- Tonsillitis
- Keywords
- Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Posted 26 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fentanyl 1 | Active comparator | Drug: FentanylFentanyl 1 micrograms (mcg)/kilogram (kg) |
| Fentanyl 2 | Active comparator | Drug: FentanylFentanyl 2 micrograms (mcg)/kilogram (kg) |
| Dex 3 | Experimental | Drug: DexmedetomidineDexmedetomidine 2 micrograms (mcg)/kilogram (kg) |
| Dex 4 | Experimental | Drug: DexmedetomidineDexmedetomidine 4 micrograms (mcg)/kilogram (kg) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All of the following criteria must be met for the potential subject to be eligible for participation:
Key exclusion criteria (6 listed)
- The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: ActiqFentanyl 1mcg/kg, Intravenous (IV) | Drug | Fentanyl 1 |
| FentanylAlso: ActiqFentanyl 2mcg/kg, Intravenous (IV) | Drug | Fentanyl 2 |
| DexmedetomidineAlso: PrecedexDexmedetomidine, 2mcg/kg, Intravenous (IV) | Drug | Dex 3 |
| DexmedetomidineAlso: PrecedexDexmedetomidine, 4mcg/kg Intravenous (IV) | Drug | Dex 4 |
Primary outcome
Time to First Morphine Dose
Time frame: up to 24 hours
Total minutes from study medication administration to time of first morphine dose.
Morphine Rescue
Time frame: up to 24 hours
Total morphine administered in the Post Anesthesia Care Unit (PACU)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21461792Pestieau 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.
Related trials for Tonsillitis
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Peritonsillar Abscess, Peritonsillar Cellulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia C Finkel, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Morphine Dose (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.