Dexmedetomidine vs Fentanyl for BMT

Otitis Clinical Trial

— DexBMT  

Official title:

Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654329
• Other study ID #: 3641
• Secondary ID: Agreement # 1069
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2008
• Last updated: March 28, 2011
• Start date: August 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2011
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

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

Related Conditions & MeSH terms

• Otitis

Intervention

Drug:
• Saline
Normal saline, given intranasally
• Fentanyl
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
• Dexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
• Dexmedetomidine
Dexmedetomidine, 2 microgram/kilogram, transmucosal route

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Research Institute	Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pain	Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)	up to 24 hours	No
Secondary	Length of Stay in PACU	Total time from PACU entry until discharge	up to 24 hours	No