Clinical Trial: Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?

Brief 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.

Detailed Summary: The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is >6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: Duration of greater auricular nerve block [ Time Frame: 24 hours ]

Patients will be observed using a CHIPPS (Children and Infants Postoperative Pain Scale) pain survey


Original Primary Outcome: Duration of greater auricular nerve block [ Time Frame: 24 hours ]

Patients will be observed using a CHIPPS pain survey


Current Secondary Outcome:

  • Nausea/Vomiting [ Time Frame: 24 hours ]
    Incidence of nausea/vomiting during 24 hour observation
  • Need for rescue analgesic [ Time Frame: 24 hours ]
    Use of rescue analgesic in hospital and by parents at home
  • Hemodynamics [ Time Frame: 1 hour ]
    Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured pre- and post-block


Original Secondary Outcome: Same as current

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: July 9, 2012
Date Started: February 2006
Date Completion:
Last Updated: March 19, 2013
Last Verified: July 2012