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

Condition(s) targeted: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma

Intervention: 0.25% Bupivacaine + Clonidine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ann & Robert H Lurie Children's Hospital of Chicago

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Duration of greater auricular nerve block

Secondary outcome:

Nausea/Vomiting

Need for rescue analgesic

Hemodynamics

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.

Minimum age: 1 Year. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

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

Related publications:

Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Coté CJ. Postoperative pain relief in children undergoing tympanomastoid surgery: is a regional block better than opioids? Anesth Analg. 2002 Apr;94(4):859-62, table of contents.

Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Coté CJ. The addition of clonidine 2 microg.kg-1 does not enhance the postoperative analgesia of a caudal block using 0.125% bupivacaine and epinephrine 1:200,000 in children: a prospective, double-blind, randomized study. Paediatr Anaesth. 2005 Jun;15(6):476-83.

Starting date: February 2006
Last updated: March 19, 2013