Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
NCT00654511
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy | |||
Official Title ICMJE | Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy. | |||
Brief Summary | The primary purpose of this study is:
| |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Tonsillitis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 101 | |||
Original Estimated Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | October 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years to 12 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00654511 | |||
Other Study ID Numbers ICMJE | 3502 Agreement #10698 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Julia C. Finkel, MD, Children's National Medical Center | |||
Study Sponsor ICMJE | Children's National Research Institute | |||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Children's National Research Institute | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |