Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Information source: Children's Research Institute
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dex vs. Fent. Intra-Oper. Hemodyn. & Post-Oper. Analg.; Analgesic Dose Response Relationship for Dexm.; Recovery Charac. of Dexmedetomidine vs. Fentanyl.
Intervention: Fentanyl (Drug); Fentanyl (Drug); Dexmedetomidine (Drug); Dexmedetomidine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Children's Research Institute Official(s) and/or principal investigator(s):
Julia C Finkel, MD, Principal Investigator, Affiliation: Childrens Research Institute
Overall contact:
Julia C Finkel, MD, Phone: 202-476-4867, Ext: 4867, Email: jfinkel@cnmc.org
Summary
The primary purpose of this study is:
1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and
post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl.
Clinical Details
Official title: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Post operative analgesia
Secondary outcome: Intraoperative hemodynamics
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All of the following criteria must be met for the potential subject to be eligible for
participation:
1. The subject is 2 to 12 years of age
2. The subject's American Society of Anesthesiologists physical status is ASA I or
II (see appendix 1).
3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy
surgery (procedures with myringotomy tube placement are allowed).
4. The subject will be hospitalized overnight after surgery
5. 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:
1. The subject has a history or a family (parent or sibling) history of malignant
hyperthermia
2. The subject has known significant renal or hepatic disorders determined by
medical history, physical examination or laboratory tests.
3. The subject has a known or suspected allergy to opioid analgesics
4. 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.
5. 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).
Locations and Contacts
Julia C Finkel, MD, Phone: 202-476-4867, Ext: 4867, Email: jfinkel@cnmc.org
Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Julia C Finkel, MD, Phone: 202-476-4867, Ext: 4867, Email: jfinkel@cnmc.org
Julia C Finkel, MD, Principal Investigator
Additional Information
Starting date: January 2005
Last updated: April 7, 2008
|
