Chronic Otitis Media Clinical Trial
Official title:
Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease) - patients scheduled for placement of bilateral myringotomy tubes Exclusion Criteria: - history of allergy to either dexmedetomidine or fentanyl - concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or ß-adrenergic antagonists. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital |
United States,
Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. Review. — View Citation
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FLACC Behavioral Pain Assessment Scale Scores | FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both |
30 mins. post-op | No |
Secondary | Recovery From General Anesthesia | Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge. | 30 mins. post-op | No |
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