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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01638052
First received: July 9, 2012
Last updated: March 19, 2013
Last verified: July 2012

July 9, 2012
March 19, 2013
February 2006
March 2008   (final data collection date for primary outcome measure)
Duration of greater auricular nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Patients will be observed using a CHIPPS (Children and Infants Postoperative Pain Scale) pain survey
Duration of greater auricular nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Patients will be observed using a CHIPPS pain survey
Complete list of historical versions of study NCT01638052 on ClinicalTrials.gov Archive Site
  • Nausea/Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Incidence of nausea/vomiting during 24 hour observation
  • Need for rescue analgesic [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Use of rescue analgesic in hospital and by parents at home
  • Hemodynamics [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured pre- and post-block
Same as current
Not Provided
Not Provided
 
Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Tympanomastoid Surgery
  • Cochlear Implant
  • Mastoidectomy
  • Cholesteatoma
Drug: 0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
  • 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.
    Intervention: Drug: 0.25% Bupivacaine + Clonidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01638052
CMH IRB 2005-12645
Yes
Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Not Provided
Ann & Robert H Lurie Children's Hospital of Chicago
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP