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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01188551
Other study ID # IRB10-00377
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 24, 2010
Last updated February 17, 2014
Start date January 2011
Est. completion date April 2012

Study information

Verified date February 2014
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
dexmedetomidine (1 µg/kg) will be administered intranasally
Fentanyl
fentanyl (2 µg/kg) will be administered intranasally
Midazolam
Sedative given pre-op.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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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