Dexmedetomidine vs Fentanyl for BMT (DexBMT)

• ClinicalTrials.gov Identifier: NCT00654329
• Recruitment Status: Completed
• First Posted: April 8, 2008
• Results First Posted: April 25, 2011
• Last Update Posted: April 25, 2011
• Sponsor: Children's National Research Institute
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer
• Information provided by: Children's National Research Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Otitis	Drug: Saline; Drug: Fentanyl; Drug: Dexmedetomidine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
• Study Start Date: August 2005
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of Pain [ Time Frame: up to 24 hours ]
   Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures :

1. Length of Stay in PACU [ Time Frame: up to 24 hours ]
   Total time from PACU entry until discharge

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 (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)

Contacts and Locations

Locations

United States, District of Columbia

Children's National Medical Center

Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Children's National Research Institute

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Julia C Finkel, MD; Children's National Research Institute

More Information

• Responsible Party: Julia C. Finkel, MD, Children's National Medical Center
• ClinicalTrials.gov Identifier: NCT00654329
• Other Study ID Numbers: 3641; Agreement # 10698
• First Posted: April 8, 2008
• Results First Posted: April 25, 2011
• Last Update Posted: April 25, 2011
• Last Verified: March 2011

Keywords provided by Children's National Research Institute:

Dexmedetomidine, transmucosal, myringotomy,

Additional relevant MeSH terms:

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Fentanyl; Dexmedetomidine; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics