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| Sponsor: | Children's Research Institute |
|---|---|
| Collaborator: |
Hospira, Inc. |
| Information provided by: | Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT00654511 |
Purpose
The primary purpose of this study is:
| Condition | Intervention | Phase |
|---|---|---|
|
Tonsillitis |
Drug: Fentanyl Drug: Dexmedetomidine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy. |
| Enrollment: | 101 |
| Study Start Date: | January 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Experimental: Dex 4
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
|
Drug: Dexmedetomidine
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Other Name: Precedex
|
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| 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'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:
Contacts and Locations| 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 |
More Information
| 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 |
| Study First Received: | April 3, 2008 |
| Results First Received: | February 23, 2011 |
| Last Updated: | March 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy, |
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Fentanyl Dexmedetomidine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Hypnotics and Sedatives Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |