Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)
This study has been completed.
Sponsor:
Children's Research Institute
Collaborator:
Hospira, Inc.
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00654511
First received: April 3, 2008
Last updated: March 28, 2011
Last verified: March 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tonsillitis |
Drug: Fentanyl Drug: Dexmedetomidine |
Phase 4 |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Tonsils and Adenoids
Drug Information available for:
Fentanyl
Fentanyl citrate
Dexmedetomidine
Dexmedetomidine hydrochloride
U.S. FDA Resources
Further study details as provided by Children's Research Institute:
Primary Outcome Measures:
- Time to First Morphine Dose [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]Total minutes from study medication administration to time of first morphine dose.
- Morphine Rescue [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]Total morphine administered in the Post Anesthesia Care Unit (PACU)
| 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 |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654511
Locations
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
Sponsors and Collaborators
Children's Research Institute
Hospira, Inc.
Investigators
| Principal Investigator: | Julia C Finkel, MD | Children's Research Institute |
More Information
No publications provided by Children's Research Institute
Additional 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 |
| Study First Received: | April 3, 2008 |
| Results First Received: | February 23, 2011 |
| Last Updated: | March 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
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 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 |
ClinicalTrials.gov processed this record on May 23, 2013