CompletedPhase 2

Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

United States56 participantsStarted 2006-02

Plain-language summary

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

Who can participate

Age range1 Year – 18 Years

SexALL

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

Inclusion Criteria: * age 1-18 years * tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery) * ASA I, II * informed consent and assent obtained Exclusion Criteria: * allergic to local anesthestic * taking chronic aspirin or Ibuprofen therapy * ASA IV * history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions * Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease. * Informed consent not obtained * Patients expected to receive dexamethasone or ondansetron intra-operative

What they're measuring

Average Observer-Rated Patient Pain Scores

Timeframe: 60 minutes

Trial details

NCT IDNCT01638052

SponsorAnn & Robert H Lurie Children's Hospital of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2020-12-23

View on ClinicalTrials.gov More Tympanomastoid Surgery trials