A Phase 4 interventional study of Fentanyl and Fentanyl in Tonsillitis, sponsored by Children's National Research Institute. Completed at 1 site in United States. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Children's National Research Institute · Phase 4, Interventional, and Treatment
The primary purpose of this study is:
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 101 is close to the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All of the following criteria must be met for the potential subject to be eligible for participation:
Exclusion Criteria:
The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fentanyl 1 micrograms (mcg)/kilogram (kg)
Drug: Fentanyl
Fentanyl 2 micrograms (mcg)/kilogram (kg)
Drug: Fentanyl
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
Drug: Dexmedetomidine
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
Drug: Dexmedetomidine
Fentanyl 1mcg/kg, Intravenous (IV)
Also known as: Actiq
Fentanyl 2mcg/kg, Intravenous (IV)
Also known as: Actiq
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
Also known as: Precedex
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Also known as: Precedex
Time to First Morphine Dose
Total minutes from study medication administration to time of first morphine dose.
Time frame: up to 24 hours
Morphine Rescue
Total morphine administered in the Post Anesthesia Care Unit (PACU)
Time frame: up to 24 hours
| Milestone | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) |
|---|---|---|---|---|
| Started | 26 | 25 | 25 | 25 |
| Completed | 26 | 25 | 25 | 25 |
| Not completed | 0 | 0 | 0 | 0 |
Total minutes from study medication administration to time of first morphine dose.
| minutes | Fentanyl 1 Microgram/Kilogram IV | Fentanyl 2 Micrograms/Kilogram IV | Dexmedetomidine 2 Microgram/Kilogram IV | Dexmedetomidine 4 Micrograms/Kilogram IV |
|---|---|---|---|---|
| Time to First Morphine Dose | 19 ± 24.8 | 43.7 ± 61.4 | 61.1 ± 89.5 | 137.6 ± 123.2 |
Total morphine administered in the Post Anesthesia Care Unit (PACU)
| micrograms/kilogram | Fentanyl 1 Microgram/Kilogram Intravenous (IV) | Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) |
|---|---|---|---|---|
| Morphine Rescue | 84 ± 37 | 95 ± 44 | 85 ± 37 | 59 ± 44 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fentanyl 1 Microgram/Kilogram Intravenous (IV) | — | 0/26 (0%) | 0/26 (0%) |
| Fentanyl 2 Micrograms/Kilogram Intravenous (IV) | — | 0/25 (0%) | 0/25 (0%) |
| Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) | — | 0/25 (0%) | 0/25 (0%) |
| Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|---|
| <=18 years | 26 | 25 | 25 | 25 | 101 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|---|
| Mean | 4.17 ± 2.33 | 4.83 ± 2.45 | 5.17 ± 2.33 | 4.92 ± 2.27 | 4.77 ± 2.34 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|
| Female | 9 | 11 | 12 | 11 | 43 |
| Male | 17 | 14 | 13 | 14 | 58 |
| Region of Enrollment(participants) | 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 |
|---|---|---|---|---|---|
| United States | 26 | 25 | 25 | 25 | 101 |
The record gives a start of Jan 2005, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2011, 2 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Children's National Research Institute →