Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Chronic Otitis Media Clinical Trial

Official title:

Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188551
• Other study ID #: IRB10-00377
• 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

• Chronic Otitis Media
• Otitis Media

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