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Phase 4 Completed N=101 Randomized Triple-blind Treatment

Dexmedetomidine vs Fentanyl for BMT

Source: ClinicalTrials.gov NCT00654329 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Incidence of Pain — 6; 11; 7; 18 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Pain
6; 11; 7; 18
SECONDARY
Length of Stay in PACU
48; 88; 46; 48

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00654329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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