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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 |
|---|---|---|
|
Dex vs. Fent. Intra-Oper. Hemodyn. & Post-Oper. Analg. Analgesic Dose Response Relationship for Dexm. Recovery Charac. of Dexmedetomidine vs. Fentanyl. |
Drug: Fentanyl Drug: Dexmedetomidine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy. |
| Estimated Enrollment: | 100 |
| 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 |
|---|---|
|
1: Active Comparator
Fentanyl
|
Drug: Fentanyl
Fentanyl 1mcg/kg, IV
|
|
2: Active Comparator
Fentanyl
|
Drug: Fentanyl
Fentanyl 2mcg/kg, IV
|
|
3: Experimental
Dexmedetomidine
|
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, IV
|
|
4: Experimental
Dexmedetomidine
|
Drug: Dexmedetomidine
Dexmedetomidine, IV, 4mcg/kg
|
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: | Children's National Medical Center ( Julia C. Finkel, MD ) |
| Study ID Numbers: | 3502, Agreement #10698 |
| Study First Received: | April 3, 2008 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00654511 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy, |
|
Anesthetics, Intravenous Neurotransmitter Agents Fentanyl Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Adrenergic Agonists Pharmacologic Actions |
Adjuvants, Anesthesia Analgesics, Non-Narcotic Anesthetics, General Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |