Clinical trial NCT01638052: Great Auricular Nerve Block for 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tympanomastoid Surgery
Cochlear Implant
Mastoidectomy
Cholesteatoma
Keywords: Tympanomastoid Surgery
Cochlear Implant
Mastoidectomy
Cholesteatoma
Pediatrics
Clonidine
Bupivacaine
Greater Auricular Nerve Block
Regional Anesthesia
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Average Observer-Rated Patient Pain Scores
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of Participants With Nausea/Vomiting
timeFrame: 24 hours
measure: Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Santhanam Suresh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Cote 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. doi: 10.1097/00000539-200204000-00015.
citation: Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Cote 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. doi: 10.1111/j.1460-9592.2005.01481.x.