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

Condition(s) targeted: To Perform a Dose Ranging Study of Nasal Transmucosal Dexmedetomidine

Intervention: Saline (Drug); Fentanyl (Drug); Dexmedetomidine (Drug); Dexmedetomidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Children's Research Institute

Official(s) and/or principal investigator(s):
Julia C Finkel, MD, Principal Investigator, Affiliation: Childrens Research Institute

Overall contact:
Julia C Finkel, MD, Phone: 202-476-4867, Ext: 4867, Email: jfinkel@cnmc.org

Relative to placebo or fentanyl,

1. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 micrograms/kilogram, will provide superior postoperative sedation as measured by post-operative agitation, pain scores and reduced need for rescue analgesia.

2. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 microgram/kilogram, will produce a more favorable time to emergence and readiness for discharge from Recovery Phase I and Phase II.

3. There will be no clinically significant difference in hemodynamic measures including heart rate and blood pressure, among the four treatment groups either intraoperatively, or during the recovery period (Recovery Phase I and Phase II).

Official title: Dexmedetomidine for Peri-Operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primary outcomes will focus on quality of emergence, recovery and postoperative analgesia in pediatric subjects ages 6 months to 6 years undergoing bilateral myringotomy with tube placement (BMT) as compared to nasal transmucosal fentanyl.

Secondary outcome: Secondary outcomes will focus on hemodynamic impact, both intraoperatively and during the recovery period.

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Both.

Criteria:

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 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)

Julia C Finkel, MD, Phone: 202-476-4867, Ext: 4867, Email: jfinkel@cnmc.org

Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Julia C Finkel, MD, Email: jfinkel@cnmc.org
Julia C Finkel, MD, Principal Investigator

Starting date: August 2005
Last updated: April 3, 2008