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OpenTrials
Completed

NCT Number: NCT00654329

Dexmedetomidine vs Fentanyl for 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.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must meet all of the following inclusion criteria to be eligible for participation:
  • The subject is 6 months to 6 years of age
  • The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
  • The subject is scheduled for elective bilateral myringotomy with tube placement
  • 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:
  • The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  • The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
  • The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
  • 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)
  • The subject has know central nervous system disease or neurological impairment
  • The subject is an ASA classification of 3 or greater (See Appendix 1)
  • The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
  • The subject refuses inhalation induction
  • The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Treatment and study plan

Saline

Drug

Normal saline, given intranasally

Other names: Normal Saline

Fentanyl

Drug

Fentanyl, nasal transmucosal, 2 micrograms/kilogram

Other names: Actiq, Fentora

Dexmedetomidine

Drug

Dexmedetomidine, transmucosal, 1 microgram/kilogram

Other names: Precedex

Primary outcomes

  1. Incidence of Pain

    Time frame: up to 24 hours

    Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary outcomes

  1. Length of Stay in PACU

    Time frame: up to 24 hours

    Total time from PACU entry until discharge

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Acronym: DexBMT

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 8, 2008
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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