Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

Phase 2

Completed

Conditions: Tympanomastoid Surgery
Mastoidectomy
Cochlear Implant
Cholesteatoma

Interventions: Drug: 0.25% Bupivacaine + Clonidine

Registration Number: NCT01638052

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25% Bupivacaine + Clonidine	0.25% Bupivacaine + Clonidine	These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.

Primary Outcome Measures

Name	Time	Method
Average Observer-Rated Patient Pain Scores	60 minutes	Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Nausea/Vomiting	24 hours	Incidence of nausea/vomiting during 24 hour observation
Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively	24 hours	Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.