Dexmedetomidine vs Fentanyl for BMT

Phase 4

Completed

• Conditions: Otitis
• Interventions: Drug: Dexmedetomidine; Drug: Saline; Drug: Fentanyl

• Registration Number: NCT00654329
• Lead Sponsor: Children's National Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2011-02-23
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-28
• Last Update Submitted: 2011-03-28
• Results First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 1microgram/kilogram	Dexmedetomidine	Dexmedetomidine 1microgram/kilogram intranasal
Normal saline placebo	Saline	Normal saline placebo intranasal
Dexmedetomidine 2 micrograms/kilogram	Dexmedetomidine	Dexmedetomidine 2 micrograms/kilogram intranasal
Fentanyl 2 micrograms/kilogram	Fentanyl	Fentanyl 2 micrograms/kilogram intranasal

Primary Outcome Measures

Name	Time	Method
Incidence of Pain	up to 24 hours	Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures

Name	Time	Method
Length of Stay in PACU	up to 24 hours	Total time from PACU entry until discharge

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States