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
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
1. The subject is 6 months to 6 years of age
2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
3. The subject is scheduled for elective bilateral myringotomy with tube placement
4. The subject's parent/legally authorized guardian has given written informed consent to participate
- Subjects will be excluded from study participation if any of the following exclusion
criteria exists:
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 or
dexmedetomidine
4. The subject has history of. cardiovascular issues which would preclude the use of
dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where
hypotension is to be avoided)
5. The subject has know central nervous system disease or neurological impairment
6. The subject is an ASA classification of 3 or greater (See Appendix 1)
7. The subject has a medical condition requiring an intravenous induction (i.e.
severe uncontrolled gastro-esophageal reflux)
8. The subject refuses inhalation induction
9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy,
tonsillectomy)
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Descriptive Information | ||||
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Brief Title ICMJE | Dexmedetomidine vs Fentanyl for BMT | |||
Official Title ICMJE | Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT) | |||
Brief Summary | A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an ?2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT. | |||
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, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Otitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | 160 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 6 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 | NCT00654329 | |||
Other Study ID Numbers ICMJE | 3641 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 |
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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 |