TerminatedNot Applicable

Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Stopped: Difficulty enrolling patients

United States40 participantsStarted 2008-09

Plain-language summary

The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

Who can participate

Age range1 Year – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA class 1 or 2 (healthy patient or acute illness) * Parental willingness to participate * Candidate for pressure-equalization tubes (PET) as determined by the ENT department Exclusion Criteria: * ASA class 3 or 4 (chronic illness or life-threatening illness) * Parental refusal to participate * Significant liver disease by history * Allergy to dexmedetomidine or midazolam * Nasal deformity * Fever in the three days prior to surgery * Nausea or vomiting * History of hypertension * History of cardiac dysfunction/disorder * Diabetes mellitus

What they're measuring

To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.

Timeframe: 2 hours post-surgery

Trial details

NCT IDNCT00778063

SponsorOchsner Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

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