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Trial record 50 of 326 for:    clonidine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638052
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : March 21, 2013
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease Intervention/treatment Phase
Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma Drug: 0.25% Bupivacaine + Clonidine Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?
Study Start Date : February 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
No Intervention: 0.25% Bupivacaine
This is our standard of care concentration
Experimental: 0.25% Bupivacaine + Clonidine
These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
Drug: 0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Nausea/Vomiting [ Time Frame: 24 hours ]
    Incidence of nausea/vomiting during 24 hour observation

  2. Need for rescue analgesic [ Time Frame: 24 hours ]
    Use of rescue analgesic in hospital and by parents at home

  3. Hemodynamics [ Time Frame: 1 hour ]
    Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured pre- and post-block

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01638052

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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago

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Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago Identifier: NCT01638052     History of Changes
Other Study ID Numbers: CMH IRB 2005-12645
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: July 2012
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Tympanomastoid Surgery
Cochlear Implant
Greater Auricular Nerve Block
Regional Anesthesia
Additional relevant MeSH terms:
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Skin Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action