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Completed

NCT Number: NCT01188551

Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.

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Key information

Conditions

Chronic Otitis Media

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
  • patients scheduled for placement of bilateral myringotomy tubes

Exclusion criteria

  • history of allergy to either dexmedetomidine or fentanyl
  • concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine (1 µg/kg) will be administered intranasally

Other names: Precedex

Fentanyl

Drug

fentanyl (2 µg/kg) will be administered intranasally

midazolam

Drug

Sedative given pre-op.

Other names: Versed

Primary outcomes

  1. FLACC Behavioral Pain Assessment Scale Scores

    Time frame: 30 mins. post-op

    FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.

    0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both

Secondary outcomes

  1. Recovery From General Anesthesia

    Time frame: 30 mins. post-op

    Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2010
Registry last updated
Apr 1, 2014

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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