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Phase 4 N=101 Randomized Triple-blind Treatment

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Tonsillitis

Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Time to First Morphine Dose — 19; 43.7; 61.1; 137.6 minutes

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Fentanyl (Drug); Dexmedetomidine (Drug)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Children's National Research Institute
Primary completion
Oct 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to First Morphine Dose
19; 43.7; 61.1; 137.6
PRIMARY
Morphine Rescue
84; 95; 85; 59

Summary

The primary purpose of this study is: 1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia. 2. To determine an analgesic dose response relationship for dexmedetomidine. 3. Compare recovery characteristics of dexmedetomidine to fentanyl.

Eligibility Criteria

Inclusion Criteria

  • All of the following criteria must be met for the potential subject to be eligible for participation:
  • The subject is 2 to 12 years of age
  • The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
  • The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
  • The subject will be hospitalized overnight after surgery
  • The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.

Exclusion Criteria

  • The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
  • 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
  • The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
  • The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00654511). 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.

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