Dexmedetomidine vs Fentanyl for BMT (DexBMT)

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

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

Study Overview

• Status: Completed
• Conditions: Otitis
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine 1microgram/kilogram; Dexmedetomidine 1microgram/kilogram intranasal	Drug: Dexmedetomidine; Dexmedetomidine, transmucosal, 1 microgram/kilogram; Other Names: Precedex; Drug: Dexmedetomidine; Dexmedetomidine, 2 microgram/kilogram, transmucosal route; Other Names: Precedex
Experimental: Dexmedetomidine 2 micrograms/kilogram; Dexmedetomidine 2 micrograms/kilogram intranasal	Drug: Dexmedetomidine; Dexmedetomidine, transmucosal, 1 microgram/kilogram; Other Names: Precedex; Drug: Dexmedetomidine; Dexmedetomidine, 2 microgram/kilogram, transmucosal route; Other Names: Precedex
Active Comparator: Fentanyl 2 micrograms/kilogram; Fentanyl 2 micrograms/kilogram intranasal	Drug: Fentanyl; Fentanyl, nasal transmucosal, 2 micrograms/kilogram; Other Names: Actiq, Fentora
Placebo Comparator: Normal saline placebo; Normal saline placebo intranasal	Drug: Saline; Normal saline, given intranasally; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pain	Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in PACU	Total time from PACU entry until discharge	up to 24 hours

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 8, 2008

Study Record Updates

• Last Update Posted (Estimate): April 25, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Dexmedetomidine, transmucosal, myringotomy,
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: 3641; Agreement # 10698