Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)
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ClinicalTrials.gov Identifier: NCT00654511 |
Recruitment Status
:
Completed
First Posted
: April 8, 2008
Results First Posted
: April 26, 2011
Last Update Posted
: April 26, 2011
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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 |
---|---|---|
Tonsillitis | Drug: Fentanyl Drug: Dexmedetomidine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy. |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Fentanyl 1
Fentanyl 1 micrograms (mcg)/kilogram (kg)
|
Drug: Fentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
Other Name: Actiq
|
Active Comparator: Fentanyl 2
Fentanyl 2 micrograms (mcg)/kilogram (kg)
|
Drug: Fentanyl
Fentanyl 2mcg/kg, Intravenous (IV)
Other Name: Actiq
|
Experimental: Dex 3
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
|
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
Other Name: Precedex
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Experimental: Dex 4
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
|
Drug: Dexmedetomidine
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Other Name: Precedex
|
- 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)

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Ages Eligible for Study: | 2 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654511
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Julia C Finkel, MD | Children's Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Julia C. Finkel, MD, Children's National Medical Center |
ClinicalTrials.gov Identifier: | NCT00654511 History of Changes |
Other Study ID Numbers: |
3502 Agreement #10698 |
First Posted: | April 8, 2008 Key Record Dates |
Results First Posted: | April 26, 2011 |
Last Update Posted: | April 26, 2011 |
Last Verified: | March 2011 |
Keywords provided by Children's Research Institute:
Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy, |
Additional relevant MeSH terms:
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Dexmedetomidine Fentanyl Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |